Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2024 – 30.09.2024
Німеччина
https://www.bfarm.de/EN/Medical-devices/Tasks/Risk-assessment-and-research/Field-corrective-actions/_node.html
Urgent Field Safety Notice for MEERA EU with/without Drive Unit by Maquet GmbH PDF, 1,013KB, File does not meet accessibility standards
Date: 30. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 31467/24
Urgent Field Safety Notice for Percept by Medtronic Inc PDF, 458KB, File does not meet accessibility standards
Date: 27. September 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - biostimulators
Reference 33104/24
Urgent Field Safety Notice for CoaguChek PT-Teststreifen by Roche Diagnostics GmbH PDF, 84KB, File does not meet accessibility standards
Date: 26. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 32304/24
Urgent Field Safety Notice for Centricity Universal Viewer Zero Footprint client by GE Healthcare PDF, 250KB, File does not meet accessibility standards
Date: 26. September 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - data processing facilities for image processing
Reference 33077/24
Urgent Field Safety Notice for Enterprise Imaging XERO Viewer by Agfa HealthCare N.V. PDF, 281KB, File does not meet accessibility standards
Date: 26. September 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - data processing facilities for image processing
Reference 33076/24
Urgent Field Safety Notice for Digital Angiography System Trinias by Shimadzu Corporation PDF, 62KB, File does not meet accessibility standards
Date: 26. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 31008/24
Urgent Field Safety Notice for Ectocare /Manuka Wound Honey by EctoMed PDF, 312KB, File does not meet accessibility standards
Date: 26. September 2024 Topics: Medical devices Type: Customer information
Product group Dressings / Pads - ointments and gels
Reference 32917/24
Urgent Field Safety Notice for McGRATH MAC Videolaryngoskop by Aircraft Medical Limited Edinburgh PDF, 412KB, File does not meet accessibility standards
Date: 26. September 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 24360/24
Urgent Field Safety Notice for Disposable Biopsy Needle Kit by Elekta Solutions AB PDF, 148KB, File does not meet accessibility standards
Date: 26. September 2024 Topics: Medical devices Type: Customer information
Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 32897/24
Urgent Field Safety Notice for AC Adapter CADD Solis by Smiths Medical ASD, Inc. (Plymouth) is no. part of ICU Medical PDF, 1MB, File does not meet accessibility standards
Date: 26. September 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 32868/24
Urgent Field Safety Notice for Ambu VivaSight 2 DLT by AMBU A/S PDF, 343KB, File does not meet accessibility standards
Date: 25. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 29660/24
Urgent Field Safety Notice for Intra-aortic balloon catheter/ MEGA IAB Catheter by Datascope Corp PDF, 425KB, File does not meet accessibility standards
Date: 25. September 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 33015/24
Urgent Field Safety Notice for IPPB Flextube Breathing Systems by Intersurgical Ltd. PDF, 685KB, File does not meet accessibility standards
Date: 25. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 30438/24
Urgent Field Safety Notice for Ultrasound system type 2300 by B-K Medical A/S PDF, 205KB, File does not meet accessibility standards
Date: 25. September 2024 Topics: Medical devices Type: Customer information
Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 32516/24
Urgent Field Safety Notice for Neonatal Breathing Circuit - NOVO BC Corrugated Neo 150SE Beatmungsschlauchsystem für Früh- und Neugeborene by R-Vent Medikal Uretim A.S. PDF, 1MB, File does not meet accessibility standards
Date: 20. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 30651/24
Urgent Field Safety Notice for ZNN BACTIGUARD Bactiguard Implants - Bone Nail End-Cap by Bactiguard (South East Asia) Sdn. Bhd. PDF, 1MB, File does not meet accessibility standards
Date: 20. September 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 31086/24
Urgent Field Safety Notice for Allura Xper,Azurion,Integris,MultiDiagnost Eleva by Philips Medical Systems Nederland B.V. PDF, 564KB, File does not meet accessibility standards
Date: 20. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 28783/24
Urgent Field Safety Notice for Merivaara Child cot 385 by Merivaara Corporation PDF, 358KB, File does not meet accessibility standards
Date: 20. September 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - furnishings
Reference 32109/24
Urgent Field Safety Notice for Meridian MRQ SLT Laser by Meridian AG PDF, 850KB, File does not meet accessibility standards
Date: 20. September 2024 Topics: Medical devices Type: Customer information
Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 31502/24
Urgent Field Safety Notice for Recharger Kit by Medtronic Inc PDF, 914KB, File does not meet accessibility standards
Date: 19. September 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - biostimulators
Reference 32276/24
Urgent Field Safety Notice for Visit smoke alarm optical by Bellman & Symfon Group AB PDF, 411KB, File does not meet accessibility standards
Date: 18. September 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - furnishings
Reference 30958/24
Urgent Field Safety Notice for BodyGuard infusion pumps by Caesarea Medical Electronics Ltd. PDF, 469KB, File does not meet accessibility standards
Date: 18. September 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 31292/24
Urgent Field Safety Notice for VARIPULSE Bi-Directional Catheter by Biosense Webster Inc PDF, 2MB, File does not meet accessibility standards
Date: 18. September 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 14579/24
Urgent Field Safety Notice for Proclarix Risk Calculator by Proteomedix AG PDF, 381KB, File does not meet accessibility standards
Date: 17. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 19537/24
Urgent Field Safety Notice for StealthStation S. Navigation by Medtronic Navigation Inc. PDF, 492KB, File does not meet accessibility standards
Date: 16. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - navigation systems
Reference 29211/24
Urgent Field Safety Notice for SCORE femoral component PCL sacrificing - cemented by Amplitude S.A.S. PDF, 478KB, File does not meet accessibility standards
Date: 16. September 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 31514/24
Urgent Field Safety Notice for LIFE 21 apheresis unit by Miltenyi Biotec GmbH PDF, 285KB, File does not meet accessibility standards
Date: 13. September 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 29839/24
Urgent Field Safety Notice for APC (Schneider Electric IT Corporation) UPS by Philips Medical Systems PDF, 600KB, File does not meet accessibility standards
Date: 13. September 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 11175/24
Urgent Field Safety Notice for Centricity High Acuity (CHA) C.C and Anesthesia by GE Healthcare Finland Oy PDF, 312KB, File does not meet accessibility standards
Date: 13. September 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 20943/24
Urgent Field Safety Notice for FastPack TSH Calibrator Kit by Qualigen Inc. PDF, 509KB, File does not meet accessibility standards
Date: 13. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 30672/24
Urgent Field Safety Notice for Spaceplus Perfusor by B. Braun Melsungen AG PDF, 204KB, File does not meet accessibility standards
Date: 13. September 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 27261/24
Urgent Field Safety Notice for CODAN ARGUS 717V by Codan Argus AG PDF, 792KB, File does not meet accessibility standards
Date: 13. September 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 28683/24
Urgent Field Safety Notice for Multiva 1.5T by Philips Healthcare (Suzhou) Co.,Ltd PDF, 83KB, File does not meet accessibility standards
Date: 12. September 2024 Topics: Medical devices Type: Customer information
Product group Electromedical fields - equipment for MR tomography
Reference 32631/23
Urgent Field Safety Notice for Soltive Laser System by Gyrus ACMI, Inc. PDF, 607KB, File does not meet accessibility standards
Date: 12. September 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - laser technology
Reference 31004/24
Urgent Field Safety Notice for Horizon DXA System by Hologic, Inc. (Danbury) PDF, 1MB, File does not meet accessibility standards
Date: 12. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - stationary radiological equipment
Reference 19361/24
Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 265KB, File does not meet accessibility standards
Date: 12. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 06757/21
Urgent Field Safety Notice for Portex Blue Line Siliconised PVC Tracheotomy Tube by Smiths Medical ASD, Inc. (Plymouth) is no. part of ICU Medical PDF, 513KB, File does not meet accessibility standards
Date: 11. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11589/24
Urgent Field Safety Notice for Kaltostat by ConvaTec Limited Deeside PDF, 1MB, File does not meet accessibility standards
Date: 11. September 2024 Topics: Medical devices Type: Customer information
Product group Dressings / Pads - dressings
Reference 23916/24
Urgent Field Safety Notice for X-RAY R/F SYSTEM FLUOROspeed by Shimadzu Corporation PDF, 50KB, File does not meet accessibility standards
Date: 11. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - stationary radiological equipment
Reference 31009/24
Urgent Field Safety Notice for ACUSON Redwood by Siemens Medical Solutions USA, Inc., Ultrasound Division PDF, 927KB, File does not meet accessibility standards
Date: 11. September 2024 Topics: Medical devices Type: Customer information
Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 27608/24
Urgent Field Safety Notice for Universal Handle, Stainless Steel, straight by Waldemar Link GmbH & Co. KG PDF, 1MB, File does not meet accessibility standards
Date: 11. September 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - bone surgery
Reference 29917/24
Urgent Field Safety Notice for Natrium Citricum 4% by Biomedica, sopl s.r.o PDF, 188KB, File does not meet accessibility standards
Date: 10. September 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 30248/24
Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 526KB, File does not meet accessibility standards
Date: 09. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12179/18
Urgent Field Safety Notice for AVVIGO+ Multi-Modality Guidance System by Boston Scientific Corporation Marlborough PDF, 250KB, File does not meet accessibility standards
Date: 09. September 2024 Topics: Medical devices Type: Customer information
Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 30524/24
Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH PDF, 290KB, File does not meet accessibility standards
Date: 09. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 29401/24
Urgent Field Safety Notice for E.g. Impactor Handle by EXACTECH, Inc. PDF, 2MB, File does not meet accessibility standards
Date: 05. September 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - bone surgery
Reference 25958/24
Urgent Field Safety Notice for BIOLOX delta cup insert Ø 32/44mm by implantcast GmbH PDF, 770KB, File does not meet accessibility standards
Date: 05. September 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 28446/24
Urgent Field Safety Notice for Minivisc Plus by Bohus BioTech AB PDF, 1MB, File does not meet accessibility standards
Date: 05. September 2024 Topics: Medical devices Type: Customer information
Product group ophthalmological technology - liquid media for ophthalmological purposes
Reference 29465/24
Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH PDF, 323KB, File does not meet accessibility standards
Date: 05. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 29400/24
Urgent Field Safety Notice for CA72-4 ELISA by IBL International GmbH PDF, 563KB, File does not meet accessibility standards
Date: 05. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 30255/24
Urgent Field Safety Notice for Formaldehydlösung gepuffert, neutral by SAV Liquid Production GmbH PDF, 1MB, File does not meet accessibility standards
Date: 05. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 28372/24
Urgent Field Safety Notice for Access TSH (3rd IS) Reagent by Immunotech PDF, 643KB, File does not meet accessibility standards
Date: 05. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 29595/24
Urgent Field Safety Notice for SPD-40 CL by Shimadzu Corporation PDF, 313KB, File does not meet accessibility standards
Date: 04. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 39383/23
Urgent Field Safety Notice for Vercise Genus by Boston Scientific Neuromodulation Corporation PDF, 278KB, File does not meet accessibility standards
Date: 04. September 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - biostimulators
Reference 12390/24
Urgent Field Safety Notice for CADD Medication Cassette Reservoir by Smiths Medical ASD, lnc. PDF, 1MB, File does not meet accessibility standards
Date: 04. September 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 29879/24
Urgent Field Safety Notice for Fujifilm Synapse PACS by FUJIFILM Medical System U.S.A., Inc. PDF, 262KB, File does not meet accessibility standards
Date: 04. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 29982/24
Urgent Field Safety Notice for Probenvorbereitungssysteme BD FACSDuet by Becton, Dickinson and Company Milpitas PDF, 488KB, File does not meet accessibility standards
Date: 04. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 27050/24
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Urgent Field Safety Notice for ViewPoint/ViewPoint 6 configured with MirthConnect by GE Healthcare GmbH München PDF, 262KB, File does not meet accessibility standards
Date: 04. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 28880/24
Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 309KB, File does not meet accessibility standards
Date: 04. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 20019/21
Urgent Field Safety Notice for Blueflow Venous Stent by Contract Medical International GmbH PDF, 1MB, File does not meet accessibility standards
Date: 04. September 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 24422/24
Urgent Field Safety Notice for Probenvorbereitungssysteme BD FACSDuet by Becton, Dickinson and Company Milpitas PDF, 488KB, File does not meet accessibility standards
Date: 03. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 26632/24
Urgent Field Safety Notice for Mako Integrated Cutting System (MICS) by Stryker Orthopaedics-Mahwah PDF, 842KB, File does not meet accessibility standards
Date: 03. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 27822/24
Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B.V. PDF, 670KB, File does not meet accessibility standards
Date: 03. September 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 26421/24
Urgent Field Safety Notice for SQUADROX-i HMO 70000+VHK7100, + VHK7000 by Maquet Cardiopulmonary GmbH PDF, 1MB, File does not meet accessibility standards
Date: 03. September 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 27790/24
Urgent Field Safety Notice for Minivisc Plus by Bohus BioTech AB PDF, 1MB, File does not meet accessibility standards
Date: 03. September 2024 Topics: Medical devices Type: Customer information
Product group ophthalmological technology - liquid media for ophthalmological purposes
Reference 27378/24
Urgent Field Safety Notice for ERYTRA EFLEXIS by Diagnostic Grifols SA PDF, 440KB, File does not meet accessibility standards
Date: 03. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 26677/24
Urgent Field Safety Notice for Atellica IM Anti-Thyroid Peroxidase (aTPO) Assay, ADVIA Centaur anti-TPO (aTPO) Assay by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 823KB, File does not meet accessibility standards
Date: 02. September 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 28991/24
Urgent Field Safety Notice for Giraffe Warmer, Panda i.e. Warmer by Datex-Ohmeda, Inc PDF, 225KB, File does not meet accessibility standards
Date: 02. September 2024 Topics: Medical devices Type: Customer information
Product group Physical therapy - climatotherapy
Reference 29251/24
Urgent Field Safety Notice for HIGH FLOW INSUFFLATION UNIT by Olympus Medical Systems Corp. PDF, 230KB, File does not meet accessibility standards
Date: 02. September 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - endoscopes
Reference 27243/24
Urgent Field Safety Notice for easy-graft CRYSTAL by Degradable Solutions AG PDF, 1MB, File does not meet accessibility standards
Date: 30. August 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - materials for implants
Reference 29185/24
Urgent Field Safety Notice for Fluido Trauma/ Fluido Standard set sterile by The Surgical Company International B.V. PDF, 521KB, File does not meet accessibility standards
Date: 29. August 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 27799/24
Urgent Field Safety Notice for TM-CA 72-4 ELISA by DRG Instruments GmbH PDF, 169KB, File does not meet accessibility standards
Date: 29. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 29227/24
Urgent Field Safety Notice for Kocher Forceps by Medline International France SAS PDF, 734KB, File does not meet accessibility standards
Date: 29. August 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - general instruments
Reference 25851/24
Urgent Field Safety Notice for Airvo 3 by Fisher & Paykel Healthcare Ltd PDF, 157KB, File does not meet accessibility standards
Date: 29. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 27426/24
Urgent Field Safety Notice for Biodesign Anal Fistula Plug by Cook Biotech Incorporated PDF, 3MB, File does not meet accessibility standards
Date: 28. August 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 26848/24
Urgent Field Safety Notice for Vanta Implantable Neurostimulator (INS) by Medtronic Inc PDF, 474KB, File does not meet accessibility standards
Date: 28. August 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - biostimulators
Reference 28018/24
Urgent Field Safety Notice for VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2 by Maquet Cardiovascular PDF, 648KB, File does not meet accessibility standards
Date: 27. August 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - endoscopes
Reference 19357/24
Urgent Field Safety Notice for Horizon/McKesson Cardiology Hemo by Change Healthcare Canada Company PDF, 2MB, File does not meet accessibility standards
Date: 27. August 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 28398/24
Urgent Field Safety Notice for Centricity Universal Viewer Zero Footprint client by GE Healthcare PDF, 239KB, File does not meet accessibility standards
Date: 27. August 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - data processing facilities for image processing
Reference 26103/24
Urgent Field Safety Notice for Serial interface cable (RS232) by Maquet Cardiopulmonary GmbH PDF, 2MB, File does not meet accessibility standards
Date: 26. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 26994/24
Urgent Field Safety Notice for DAILIES TOTAL1 and TOTAL30 soft contact lens by Alcon Laboratories, Inc. PDF, 370KB, File does not meet accessibility standards
Date: 26. August 2024 Topics: Medical devices Type: Customer information
Product group ophthalmological technology - contact lenses
Reference 26969/24
Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V. PDF, 374KB, File does not meet accessibility standards
Date: 26. August 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - stationary radiological equipment
Reference 21319/24
Urgent Field Safety Notice for Dehas - Quality Mix Flowmeter by DEHAS Medizintechnik GmbH PDF, 473KB, File does not meet accessibility standards
Date: 23. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 28402/24
Urgent Field Safety Notice for Multicath 2 by VYGON GmbH & Co. KG PDF, 234KB, File does not meet accessibility standards
Date: 22. August 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 28032/24
Urgent Field Safety Notice for M Medikation by Meierhofer AG PDF, 417KB, File does not meet accessibility standards
Date: 21. August 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 25850/24
Urgent Field Safety Notice for Aptio Automation by Inpeco SA PDF, 463KB, File does not meet accessibility standards
Date: 21. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 34471/23
Urgent Field Safety Notice for Atellica CI, Atellica IM und ADVIA Centaur CA 19-9 by Siemens Healthcare Diagnostics Products Ltd. PDF, 413KB, File does not meet accessibility standards
Date: 21. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 26093/24
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 304KB, File does not meet accessibility standards
Date: 21. August 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 26451/24
Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH PDF, 286KB, File does not meet accessibility standards
Date: 21. August 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 27850/24
Urgent Field Safety Notice for Easy Connect Apapter for 2 to 4 Lumen Jet Catheter by Carl Reiner GmbH PDF, 2MB, File does not meet accessibility standards
Date: 21. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 22214/24
Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH PDF, 286KB, File does not meet accessibility standards
Date: 20. August 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 27853/24
Urgent Field Safety Notice for ACUSON Maple/Maple Select ultrasound system by Siemens Medical Solutions USA, Inc. Ultrasound PDF, 298KB, File does not meet accessibility standards
Date: 20. August 2024 Topics: Medical devices Type: Customer information
Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 27614/24
Urgent Field Safety Notice for ACUSON Juniper Diagnostic Ultrasound System by Siemens Medical Solutions USA, Inc., Ultrasound Division PDF, 292KB, File does not meet accessibility standards
Date: 20. August 2024 Topics: Medical devices Type: Customer information
Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 27610/24
Urgent Field Safety Notice for Extremity drape by Mölnlycke Health Care AB PDF, 2MB, File does not meet accessibility standards
Date: 20. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 26409/24
Urgent Field Safety Notice for SanaBike 500/ERG 910 plus, SanaBike 1000/ERG 911 plus, SanaComfort 1000/ERG 911 Comfort, SanaCouch 1000/ ERG 911L, SanaCardio 1000/ERG 911LS by Ganshorn Medizin Electronic GmbH PDF, 661KB, File does not meet accessibility standards
Date: 19. August 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - functional diagnostics by way of gas exchange and exercise
Reference 25447/24
Urgent Field Safety Notice for SOPHIE by Fritz Stephan GmbH PDF, 486KB, File does not meet accessibility standards
Date: 16. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 26640/24
Urgent Field Safety Notice for SIGNA (Artist, Voyager, Creator, Explorer, Prime, Victor, MR355, MR360 und MR380) by GE HEALTHCARE (TIANJIN) COMPANY LIMITED PDF, 630KB, File does not meet accessibility standards
Date: 15. August 2024 Topics: Medical devices Type: Customer information
Product group Electromedical fields - equipment for MR tomography
Reference 19299/24
Urgent Field Safety Notice for Corpuls CPR by GS Elektromedizinische Geräte G. Stemple GmbH PDF, 346KB, File does not meet accessibility standards
Date: 15. August 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 26110/24
Urgent Field Safety Notice for Power Express Centrifuge by Beckman Coulter, Inc. PDF, 1MB, File does not meet accessibility standards
Date: 15. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 24940/24
Urgent Field Safety Notice for IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent by Beckman Coulter, Inc. PDF, 281KB, File does not meet accessibility standards
Date: 14. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 27073/24
Urgent Field Safety Notice for BLUSelect®, BLUgriggs® and BLUperc® Trach products by Smiths Medical ASD Inc. Minneapolis PDF, 440KB, File does not meet accessibility standards
Date: 14. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 26829/24
Urgent Field Safety Notice for Miami J Cervical Collar by Össur hf PDF, 779KB, File does not meet accessibility standards
Date: 14. August 2024 Topics: Medical devices Type: Customer information
Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 27047/24
Urgent Field Safety Notice for TENDON ANCHORS 8 by Smith & Nephew, Inc., Endoscopy Division PDF, 183KB, File does not meet accessibility standards
Date: 14. August 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 27072/24
Urgent Field Safety Notice for Aisys CS2, Avance CS2, Avance CS2 Pro, Aisys, Avance, Amingo, Aespire 100, Aespire View, Aespire 7900, and Aespire 7100 anesthesia devices equipped with the Auxiliary Common Gas Outlet (ACGO) by Datex-Ohmeda, Inc. PDF, 654KB, File does not meet accessibility standards
Date: 13. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 26602/24
Urgent Field Safety Notice for LymphoTrack Dx /GH FR1/2/3 Assay Panel - MiSeq & LymphoTrack Dx IGH FR3 Assay Panel - MiSeq by Invivoscribe Technologies, Inc PDF, 2MB, File does not meet accessibility standards
Date: 12. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 22768/23
Urgent Field Safety Notice for Corneal Irrigator in Medline's Caresets and Sterile Procedure Trays by Medline International France SAS PDF, 557KB, File does not meet accessibility standards
Date: 12. August 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - eye surgery
Reference 26631/24
Urgent Field Safety Notice for AIA-PACK MULTI ANALYTE CONTROL by Tosoh Europe NV PDF, 70KB, File does not meet accessibility standards
Date: 12. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 26486/23
Urgent Field Safety Notice for Vercise Genus by Boston Scientific Neuromodulation Corporation PDF, 407KB, File does not meet accessibility standards
Date: 12. August 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - biostimulators
Reference 26467/24
Urgent Field Safety Notice for HLM Tubing Set/HLM-Schlauchset by Maquet Cardiopulmonary GmbH PDF, 2MB, File does not meet accessibility standards
Date: 12. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 26426/24
Urgent Field Safety Notice for BD Phoenix M50 instrument, BD Phoenix M100 instrument by Becton, Dickinson and Company PDF, 507KB, File does not meet accessibility standards
Date: 12. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 24675/24
Urgent Field Safety Notice for IRISpec CA/CB/CC by Beckman Coulter Ireland Inc. PDF, 805KB, File does not meet accessibility standards
Date: 12. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 24628/24
Urgent Field Safety Notice for Diverse MiniMed Insulin Pumps by Medtronic Minimed PDF, 878KB, File does not meet accessibility standards
Date: 12. August 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 12658/22
Urgent Field Safety Notice for ATELLICA CH / ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 196KB, File does not meet accessibility standards
Date: 09. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 26096/24
Urgent Field Safety Notice for XF-1600 by Sysmex Japan Corporation PDF, 1MB, File does not meet accessibility standards
Date: 09. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 24161/24
Urgent Field Safety Notice for Flocare Infinity III by Nutricia Medical Devices BV PDF, 415KB, File does not meet accessibility standards
Date: 07. August 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 26094/24
Urgent Field Safety Notice for NUTRIFIT by PENTAFERTE ITALIA s.r.l. PDF, 257KB, File does not meet accessibility standards
Date: 07. August 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 25946/24
Urgent Field Safety Notice for LIAISON Testosterone xt by DiaSorin Inc. PDF, 135KB, File does not meet accessibility standards
Date: 07. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 25915/24
Urgent Field Safety Notice for MONOPLUS, MONOSYN, NOVOSYN, NOVOSYN CHD by B. Braun Surgical S.A. PDF, 724KB, File does not meet accessibility standards
Date: 06. August 2024 Topics: Medical devices Type: Customer information
Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 25892/24
Urgent Field Safety Notice for WallFlex & Agile Esophageal Stent Systems by Boston Scientific Corporation Marlborough PDF, 270KB, File does not meet accessibility standards
Date: 06. August 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 25482/24
Urgent Field Safety Notice for Axis-Shield Active-B12 (Holotranscobalamin) EIA by Axis-Shield Diagnostics Limited PDF, 190KB, File does not meet accessibility standards
Date: 05. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 25607/24
Urgent Field Safety Notice for 1.2 K+-Draht, Lanzette, 150mm by Medartis AG PDF, 132KB, File does not meet accessibility standards
Date: 05. August 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 25226/24
Urgent Field Safety Notice for Proteus XR/a by GE Hualun Medical Systems Co Ltd PDF, 233KB, File does not meet accessibility standards
Date: 05. August 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - stationary radiological equipment
Reference 25436/24
Urgent Field Safety Notice for Trilogy Evo, Trilogy Evo O2, Trilogy EV300 by Respironics, Inc. Pittsburgh PDF, 588KB, File does not meet accessibility standards
Date: 02. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 22117/24
Urgent Field Safety Notice for PST 500 by Baxter Medical Systems GmbH + Co. KG PDF, 571KB, File does not meet accessibility standards
Date: 02. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 21065/24
Urgent Field Safety Notice for Impella 5.5; Impella CP®(both with SmartAssist®) by ABIOMED Inc. PDF, 530KB, File does not meet accessibility standards
Date: 02. August 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 24741/24
Urgent Field Safety Notice for HYBRID by BALT Extrusion PDF, 298KB, File does not meet accessibility standards
Date: 02. August 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 25274/24
Urgent Field Safety Notice for Marodyne LiV by BTT Health GmbH PDF, 265KB, File does not meet accessibility standards
Date: 01. August 2024 Topics: Medical devices Type: Customer information
Product group Physical therapy - massage / mobility devices
Reference 25043/24
Urgent Field Safety Notice for BiPAP A40 Pro, BiPAP A40 EFL, BiPAP A30 EFL by Respironics, Inc. Pittsburgh PDF, 342KB, File does not meet accessibility standards
Date: 01. August 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 20133/24
Urgent Field Safety Notice for HeartMate 3 System Controller by Thoratec Corporation PDF, 717KB, File does not meet accessibility standards
Date: 01. August 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - artificial hearts
Reference 24346/24
Urgent Field Safety Notice for BRAUN THERMOSCAN PRO 6000 by Welch Allyn Ltd PDF, 393KB, File does not meet accessibility standards
Date: 01. August 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 20665/24
Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter Inc. PDF, 846KB, File does not meet accessibility standards
Date: 01. August 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 23245/24
Urgent Field Safety Notice for Stirnfräser, fein by Unintech GmbH PDF, 67KB, File does not meet accessibility standards
Date: 31. July 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - bone surgery
Reference 22861/24
Urgent Field Safety Notice for Opera T90SH, Opera T90SHX by General Medical Merate S.p.A. PDF, 507KB, File does not meet accessibility standards
Date: 31. July 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 19051/24
Urgent Field Safety Notice for LUISA by Löwenstein Medical Technology GmbH + Co. KG PDF, 2MB, File does not meet accessibility standards
Date: 30. July 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 24414/24
Urgent Field Safety Notice for HYALOBARRIER GEL ENDO, HYALOBARRIER GEL by Anika Therapeutics S.r.l. PDF, 648KB, File does not meet accessibility standards
Date: 30. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - materials for implants
Reference 24176/24
Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 2MB, File does not meet accessibility standards
Date: 30. July 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - artificial hearts
Reference 21994/20
Urgent Field Safety Notice for ALFA-Flex u. BETA-Flex Brace Fußabduktionsschienen by Semeda Medizinische Instrumente e.K. PDF, 1MB, File does not meet accessibility standards
Date: 30. July 2024 Topics: Medical devices Type: Customer information
Product group Orthopaedic / Rehabilitation technology - orthopaedic shoes
Reference 23807/24
Urgent Field Safety Notice for Olympus EndoDis Pro by Ecolab Deutschland GmbH PDF, 172KB, File does not meet accessibility standards
Date: 30. July 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 24097/24
Urgent Field Safety Notice for suPARnostic Auto Flex ELISA by ViroGates A/S PDF, 154KB, File does not meet accessibility standards
Date: 29. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 24104/24
Urgent Field Safety Notice for mySugr Bolus Calculator by mySugr GmbH PDF, 3MB, File does not meet accessibility standards
Date: 29. July 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - medical apps
Reference 24144/24
Urgent Field Safety Notice for Salivary Testosterone ELISA by DRG Instruments GmbH PDF, 534KB, File does not meet accessibility standards
Date: 29. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 23918/24
Urgent Field Safety Notice for Powerheart G5 AED by ZOLL Medical Corporation Deerfield PDF, 254KB, File does not meet accessibility standards
Date: 29. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 18345/24
Urgent Field Safety Notice for IRISpec CA/CB/CC by Beckman Coulter Ireland Inc. PDF, 765KB, File does not meet accessibility standards
Date: 29. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 23994/24
Urgent Field Safety Notice for Inspire IV Pulsgenerators (IPG) by Inspire Medical Systems, Inc. PDF, 126KB, File does not meet accessibility standards
Date: 29. July 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - biostimulators
Reference 23557/24
Urgent Field Safety Notice for Change Healthcare Cardiology by Change Healthcare Canada Company PDF, 662KB, File does not meet accessibility standards
Date: 25. July 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 23168/24
Urgent Field Safety Notice for CT LUCIA 221P by Carl Zeiss Meditec AG PDF, 1,022KB, File does not meet accessibility standards
Date: 25. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 19734/24
Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter Inc. PDF, 322KB, File does not meet accessibility standards
Date: 24. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 24151/24
Urgent Field Safety Notice for VITROS XT Chemistry Products ALB-TP Slides by Ortho-Clinical Diagnostics, Inc. PDF, 517KB, File does not meet accessibility standards
Date: 24. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 23248/24
Urgent Field Safety Notice for RAL Diff-Quik Fixative solution by RAL DIAGNOSTICS PDF, 641KB, File does not meet accessibility standards
Date: 24. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 16310/24
Urgent Field Safety Notice for S-Monovette Heparin by Sarstedt AG & Co PDF, 520KB, File does not meet accessibility standards
Date: 24. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 22073/24
Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH PDF, 324KB, File does not meet accessibility standards
Date: 24. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 19548/24
Urgent Field Safety Notice for BioPince, BioPinceUltra and TruCore II by Argon Medical Devices, Inc. PDF, 689KB, File does not meet accessibility standards
Date: 23. July 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - general instruments
Reference 21735/24
Urgent Field Safety Notice for CorPatch easy by Leonhard Lang Medizintechnik GmbH PDF, 303KB, File does not meet accessibility standards
Date: 23. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 21724/24
Urgent Field Safety Notice for WAVEWRITER ALPHA IPG KIT-WAVEWRITERALPHA 16IPG KIT by Boston Scientific Neuromodulation Corporation PDF, 202KB, File does not meet accessibility standards
Date: 23. July 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - biostimulators
Reference 23433/24
Urgent Field Safety Notice for MONOPLUS, NOVOSYN, NOVOSYN CHD by B. Braun Surgical S.A. PDF, 553KB, File does not meet accessibility standards
Date: 23. July 2024 Topics: Medical devices Type: Customer information
Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 23954/24
Urgent Field Safety Notice for Aural Ventilation Tubes by Exmoor Plastics Limited PDF, 2MB, File does not meet accessibility standards
Date: 22. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 23332/24
Urgent Field Safety Notice for Vantage Orian, Vantage Elan, Vantage Titan by Canon Medical Systems Corporation PDF, 360KB, File does not meet accessibility standards
Date: 22. July 2024 Topics: Medical devices Type: Customer information
Product group Electromedical fields - equipment for MR tomography
Reference 23606/24
Urgent Field Safety Notice for SPII Model Lubinus - Hip Prosthesis Stem by Waldemar Link GmbH & Co. KG PDF, 929KB, File does not meet accessibility standards
Date: 22. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 03790/24
Urgent Field Safety Notice for HPS 2.0 Rod coupler, S=25N/mm, 27mm by Paradigm Spine GmbH PDF, 229KB, File does not meet accessibility standards
Date: 22. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 23795/24
Urgent Field Safety Notice for IntelliVue MX400-550 by Philips Medizin Systeme Böblingen GmbH PDF, 1MB, File does not meet accessibility standards
Date: 22. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 21415/24
Urgent Field Safety Notice for Corneal Irrigator by Bausch & Lomb GmbH PDF, 1MB, File does not meet accessibility standards
Date: 22. July 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - eye surgery
Reference 21632/24
Urgent Field Safety Notice for VarioXX² Rollstuhl by Novacare GmbH PDF, 4MB, File does not meet accessibility standards
Date: 22. July 2024 Topics: Medical devices Type: Customer information
Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 21728/24
Urgent Field Safety Notice for Multiple UDI numbers affected, IOL models in a "Safeloader" (SL) packaging by HumanOptics Holding AG PDF, 1MB, File does not meet accessibility standards
Date: 22. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 22139/24
Urgent Field Safety Notice for >Silverline ventricular catheter 8F by Spiegelberg GmbH & Co. KG PDF, 1MB, File does not meet accessibility standards
Date: 22. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 22766/24
Urgent Field Safety Notice for Silicone Sheets, Discs and Strips by Exmoor Plastics Limited PDF, 1MB, File does not meet accessibility standards
Date: 20. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 23385/24
Urgent Field Safety Notice for iVascular sergeant 18 by Life Vascular Devices (LVD) Biotech S.L. PDF, 268KB, File does not meet accessibility standards
Date: 20. July 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 23354/24
Urgent Field Safety Notice for Fabian HFO / HFOi by Acutronic Medical Systems AG PDF, 635KB, File does not meet accessibility standards
Date: 18. July 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 12264/24
Urgent Field Safety Notice for Accutome Trephines by MicroSurgical Technology PDF, 373KB, File does not meet accessibility standards
Date: 17. July 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - eye surgery
Reference 22597/24
Urgent Field Safety Notice for Trinias by Shimadzu Corporation PDF, 230KB, File does not meet accessibility standards
Date: 16. July 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - mobile radiological diagnostic facilities
Reference 21809/24
Urgent Field Safety Notice for Intuy Knee by Reboocon Bionics B.V. PDF, 273KB, File does not meet accessibility standards
Date: 16. July 2024 Topics: Medical devices Type: Customer information
Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 14145/24
Urgent Field Safety Notice for Olympus EndoDis Pro by Ecolab Deutschland GmbH PDF, 154KB, File does not meet accessibility standards
Date: 16. July 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 16923/24
Urgent Field Safety Notice for Varilind by OTG Handels GmbH PDF, 565KB, File does not meet accessibility standards
Date: 16. July 2024 Topics: Medical devices Type: Customer information
Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 21426/24
Urgent Field Safety Notice for Vasoview Hemopro Endoscopic Vessel Harvesting Sys. by Maquet Cardiovascular PDF, 243KB, File does not meet accessibility standards
Date: 16. July 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - endoscopes
Reference 20746/24
Urgent Field Safety Notice for Diverse Produkte (Kompressionsstrümpfe, Bandagen, Orthesen) by Bauerfeind AG PDF, 263KB, File does not meet accessibility standards
Date: 16. July 2024 Topics: Medical devices Type: Customer information
Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 20712/24
Urgent Field Safety Notice for Soltive Laser System by Gyrus ACMI, Inc. PDF, 98KB, File does not meet accessibility standards
Date: 16. July 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - laser technology
Reference 20481/24
Urgent Field Safety Notice for ProteusPLUS, ProteusONE by IBA (Ion Beam Applications) PDF, 2MB, File does not meet accessibility standards
Date: 15. July 2024 Topics: Medical devices Type: Customer information
Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 22177/24
Urgent Field Safety Notice for CareLink 2090 Programmer by Medtronic Inc PDF, 127KB, File does not meet accessibility standards
Date: 15. July 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - defibrillators
Reference 22451/24
Urgent Field Safety Notice for VHK/VKMO/CTP containing the component vacuum-tight reservoir by Maquet Cardiopulmonary GmbH PDF, 6MB, File does not meet accessibility standards
Date: 15. July 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 22548/24
Urgent Field Safety Notice for LinkSymphoKnee - Patella Sizing Template, Stainles by Waldemar Link GmbH & Co. KG PDF, 4MB, File does not meet accessibility standards
Date: 15. July 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - bone surgery
Reference 20641/24
Urgent Field Safety Notice for SENSE XL Torso coil (1.5T and 3.0T) by PHILIPS HEALTHCARE FRANCE PDF, 1MB, File does not meet accessibility standards
Date: 12. July 2024 Topics: Medical devices Type: Customer information
Product group Electromedical fields - equipment for MR tomography
Reference 18204/24
Urgent Field Safety Notice for VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody by Roche Diagnostics GmbH PDF, 450KB, File does not meet accessibility standards
Date: 12. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 20421/24
Urgent Field Safety Notice for Hugo-System für roboterassistierte Chirurgie(RAS)-Handgelenkinstrumente, steriles Schnittstellenmodul (SIM), Endoskopadapter (EA) by Covidien llc PDF, 801KB, File does not meet accessibility standards
Date: 12. July 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 13394/23
Urgent Field Safety Notice for ProteusPLUS, ProteusONE by IBA (Ion Beam Applications) PDF, 197KB, File does not meet accessibility standards
Date: 12. July 2024 Topics: Medical devices Type: Customer information
Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 22174/24
Urgent Field Safety Notice for CADD 50 mL and 100 mL and 250 ML Medication Cassette Reservoirs with Flow Stop when used with CADD-Legacy infusion pumps by Smiths Medical ASD, lnc. PDF, 580KB, File does not meet accessibility standards
Date: 12. July 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 31521/22
Urgent Field Safety Notice for EndoPredict QS Kit Uno & EndoPredict QS KIt Duo by Myriad International GmbH PDF, 232KB, File does not meet accessibility standards
Date: 12. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 20651/24
Urgent Field Safety Notice for BlueDiver Dot Myositis12 SAE IgG by D-tek SA PDF, 785KB, File does not meet accessibility standards
Date: 12. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 21811/24
Urgent Field Safety Notice for MEGADYNE, MEGA SOFT,MEGA 2000 REUSABLE PATIENT RETURN ELECTRODES by Megadyne Medical Products Inc. PDF, 188KB, File does not meet accessibility standards
Date: 11. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 19188/24
Urgent Field Safety Notice for Ringlight fiber by LSO Medical PDF, 386KB, File does not meet accessibility standards
Date: 11. July 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - laser technology
Reference 20074/24
Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH PDF, 300KB, File does not meet accessibility standards
Date: 11. July 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 19769/24
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 304KB, File does not meet accessibility standards
Date: 10. July 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 21891/24
Urgent Field Safety Notice for Global Total LP single step medium, 60mL by CooperSurgical, Inc. Trumbull PDF, 411KB, File does not meet accessibility standards
Date: 10. July 2024 Topics: Medical devices Type: Customer information
Product group Physical therapy - others
Reference 21440/24
Urgent Field Safety Notice for Hookup by Medivators (Cantel Medical) PDF, 2MB, File does not meet accessibility standards
Date: 10. July 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 21160/24
Urgent Field Safety Notice for MobileDiagnost wDR by Philips Medical Systems DMC GmbH PDF, 2MB, File does not meet accessibility standards
Date: 10. July 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - stationary radiological equipment
Reference 15599/24
Urgent Field Safety Notice for Olympus Everest Bipolar Cutting Forceps by Gyrus ACMI Inc. PDF, 359KB, File does not meet accessibility standards
Date: 09. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 20669/24
Urgent Field Safety Notice for Trinias by Shimadzu Corporation PDF, 44KB, File does not meet accessibility standards
Date: 09. July 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - mobile radiological diagnostic facilities
Reference 21823/24
Urgent Field Safety Notice for CPT Hip System Femoral Stem by Zimmer Switzerland Manufacturing GmbH PDF, 562KB, File does not meet accessibility standards
Date: 09. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 21393/24
Urgent Field Safety Notice for Oncomine Dx Express Test Panel by Life Technologies Corporation US PDF, 284KB, File does not meet accessibility standards
Date: 09. July 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 21764/24
Urgent Field Safety Notice for exoplan by exocad GmbH PDF, 630KB, File does not meet accessibility standards
Date: 09. July 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - software for computer-based treatment
Reference 20731/24
Urgent Field Safety Notice for FiberTak Suture Anchor with #2 FiberWire CL, FiberTak Suture Anchor, Double Loaded with 1.3 mm SutureTape, FiberTak Suture Anchor, Double Loaded with 1.3 mm SutureTape, FiberTak Suture Anchor #2 FiberWire CL by Arthrex Inc. PDF, 147KB, File does not meet accessibility standards
Date: 08. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 21622/24
Urgent Field Safety Notice for Spaceplus Infusomat by B. Braun Melsungen AG PDF, 146KB, File does not meet accessibility standards
Date: 08. July 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 19748/24
Urgent Field Safety Notice for Philips IntelliVue Information Center iX by Philips Medizin Systeme Boblingen GmbH PDF, 230KB, File does not meet accessibility standards
Date: 05. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 12198/24
Urgent Field Safety Notice for Arctic Sun 5000 by Medivance, Inc. PDF, 296KB, File does not meet accessibility standards
Date: 05. July 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 21581/24
Urgent Field Safety Notice for NIM Vital Console, NIM Vital Patient Interface 4 Channel, NIM Vital Console Refurbished, NIM Vital Patient Interface 4 Channel Refurbished by Medtronic Xomed Inc. PDF, 316KB, File does not meet accessibility standards
Date: 05. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 20972/24
Urgent Field Safety Notice for Puritan Bennett 500 Series Ventilator by Covidien llc PDF, 2MB, File does not meet accessibility standards
Date: 05. July 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 20855/24
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 621KB, File does not meet accessibility standards
Date: 05. July 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 19067/24
Urgent Field Safety Notice for Centricity High Acuity (CHA) C.C and Anesthesia by GE Healthcare Finland Oy PDF, 347KB, File does not meet accessibility standards
Date: 04. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 15708/24
Urgent Field Safety Notice for IntelliVue X3 by Philips Medizin Systeme Boblingen GmbH PDF, 374KB, File does not meet accessibility standards
Date: 03. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 18819/24
Urgent Field Safety Notice for VENUS by HumanTech Germany GmbH PDF, 629KB, File does not meet accessibility standards
Date: 02. July 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 20710/24
Urgent Field Safety Notice for Alcotest 7000 med by Dräger Safety AG & Co. KGaA PDF, 230KB, File does not meet accessibility standards
Date: 02. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - functional diagnostics by way of gas exchange and exercise
Reference 20480/24
Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS PDF, 110KB, File does not meet accessibility standards
Date: 02. July 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 21142/24
Urgent Field Safety Notice for Capio SLIM Suture Capturing Device by Boston Scientific Corporation Marlborough PDF, 273KB, File does not meet accessibility standards
Date: 01. July 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - general instruments
Reference 20844/24
Urgent Field Safety Notice for STARKLING / Starkling Anesthesia by Starkling e.K. PDF, 296KB, File does not meet accessibility standards
Date: 01. July 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 20347/24