Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2024 – 31.12.2024
Німеччина
Urgent Field Safety Notice for Idylla Instrument by Biocartis PDF, 292KB, File does not meet accessibility standards
Date: 30. December 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 43166/24
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 304KB, File does not meet accessibility standards
Date: 30. December 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 44688/24
Urgent Field Safety Notice for Tec 6 Plus, Tec 820, Tec 850 by Datex-Ohmeda, Inc. PDF, 315KB, File does not meet accessibility standards
Date: 30. December 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 44955/24
Urgent Field Safety Notice for 2.8 TriLock Screw 14mm, HD7, 5/Pkg by Medartis AG PDF, 581KB, File does not meet accessibility standards
Date: 27. December 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 44439/24
Urgent Field Safety Notice for Nobel Biocare N1 TiUltra TCC NP 3.5x13mm by Nobel Biocare AB PDF, 580KB, File does not meet accessibility standards
Date: 27. December 2024 Topics: Medical devices Type: Customer information
Product group Dental products - dental implants
Reference 44859/24
Urgent Field Safety Notice for 4008H, B, S. Art. Prometheus by Fresenius Medical Care AG & Co. KGaA PDF, 140KB, File does not meet accessibility standards
Date: 23. December 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 45042/24
Urgent Field Safety Notice for IRON 2 by Roche Diagnostics GmbH PDF, 226KB, File does not meet accessibility standards
Date: 20. December 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 07124/21
Urgent Field Safety Notice for Figulla Flex II ASD by Occlutech GmbH PDF, 5MB, File does not meet accessibility standards
Date: 20. December 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - cardiac surgery
Reference 43753/24
Urgent Field Safety Notice for Vantage Orian, Vantage Elan, Vantage Titan by Canon Medical Systems Corporation PDF, 344KB, File does not meet accessibility standards
Date: 20. December 2024 Topics: Medical devices Type: Customer information
Product group Electromedical fields - equipment for MR tomography
Reference 44690/24
Urgent Field Safety Notice for Forceps/Irrigation Plug (Isolated Type) by Olympus Medical Systems Corp. PDF, 386KB, File does not meet accessibility standards
Date: 20. December 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - endoscopes
Reference 42411/24
Urgent Field Safety Notice for Probe 3 + Probe 3 XL + Silverline ventricular probe with cranial bolt + Probe 3PN + Probe 3PN with Trocar + IAP catheter by Spiegelberg GmbH & Co. KG PDF, 1MB, File does not meet accessibility standards
Date: 20. December 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 42713/24
Urgent Field Safety Notice for DeltaCut Biopsy by PAJUNK GmbH Medizintechnologie PDF, 1MB, File does not meet accessibility standards
Date: 20. December 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - general instruments
Reference 43277/24
Urgent Field Safety Notice for Oxylog 3000plus by Drägerwerk AG & Co. KGaA PDF, 176KB, File does not meet accessibility standards
Date: 20. December 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 14632/23
Urgent Field Safety Notice for MSOT Acuity Echo CE by iThera Medical GmbH PDF, 143KB, File does not meet accessibility standards
Date: 19. December 2024 Topics: Medical devices Type: Customer information
Product group Electromedical fields - equipment for MR tomography
Reference 43690/24
Urgent Field Safety Notice for OEC Elite, OEC 3D, OEC 9900, OEC 9800 by GE OEC Medical Systems, Inc. PDF, 291KB, File does not meet accessibility standards
Date: 19. December 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - mobile radiological diagnostic facilities
Reference 43777/24
Urgent Field Safety Notice for QIAsymphony DSP DNA Midi Kit by QIAGEN GmbH PDF, 305KB, File does not meet accessibility standards
Date: 19. December 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 43973/24
Urgent Field Safety Notice for THUNDERBEAT by Olympus Medical Systems Corp. PDF, 394KB, File does not meet accessibility standards
Date: 19. December 2024 Topics: Medical devices Type: Customer information
Product group Ultrasonics - ultrasonic therapeutic equipment
Reference 44530/24
Urgent Field Safety Notice for OP-Leuchtensystem (marLED E, marLED X) by KLS Martin S. & Co.KG PDF, 3MB, File does not meet accessibility standards
Date: 19. December 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 43243/24
Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH PDF, 283KB, File does not meet accessibility standards
Date: 18. December 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 43147/24
Urgent Field Safety Notice for Single Use Mechanical Lithotriptor V by Olympus Medical Systems Corp. PDF, 770KB, File does not meet accessibility standards
Date: 18. December 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 44292/24
Urgent Field Safety Notice for Blutkultur-Adapter by Sarstedt AG & Co PDF, 372KB, File does not meet accessibility standards
Date: 17. December 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 43272/24
Urgent Field Safety Notice for Centricity PACS by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 315KB, File does not meet accessibility standards
Date: 17. December 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 30752/24
Urgent Field Safety Notice for DLP One-Piece Pediatric Arterial Cannula 8 Fr. DLP One-Piece Pediatric Arterial Cannula 14 Fr. EOPA - Elongated One Piece Arterial Cannula 18 Fr.; EOPA - Elongated One Piece Arterial Cannula 22 Fr.; Select Series Angled Tip Arter by Medtronic Inc PDF, 538KB, File does not meet accessibility standards
Date: 16. December 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 43678/24
Urgent Field Safety Notice for CGM CLINICAL Medication by CompuGroup Medical Deutschland AG PDF, 220KB, File does not meet accessibility standards
Date: 16. December 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 43110/24
Urgent Field Safety Notice for Trilogy Evo, Trilogy Evo O2, Trilogy EV300 by Respironics, Inc. Pittsburgh PDF, 893KB, File does not meet accessibility standards
Date: 16. December 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 32707/24
Urgent Field Safety Notice for diverse by Coloplast A/S PDF, 562KB, File does not meet accessibility standards
Date: 16. December 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 42731/24
Urgent Field Safety Notice for Glucose Liquicolor by HUMAN Gesellschaft für Biochemica und Diagnostica mbH PDF, 60KB, File does not meet accessibility standards
Date: 16. December 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 42662/24
Urgent Field Safety Notice for MEDRAD Centargo by Imaxeon Pty Ltd Imaxeon is a subsidiary company of Bayer PDF, 1MB, File does not meet accessibility standards
Date: 16. December 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 43923/24
Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH PDF, 286KB, File does not meet accessibility standards
Date: 13. December 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 43157/24
Urgent Field Safety Notice for Accu-Chek Spirit 3.15 ml Plastic Cartridge by Roche Diabetes Care GmbH PDF, 176KB, File does not meet accessibility standards
Date: 12. December 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 41279/24
Urgent Field Safety Notice for Synergy RF Console by Arthrex Inc. PDF, 2MB, File does not meet accessibility standards
Date: 12. December 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 41699/24
Urgent Field Safety Notice for ELITe InGenius Consumable Set by ElitechGroup S.p.A. PDF, 515KB, File does not meet accessibility standards
Date: 12. December 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - microbiological products
Reference 42131/24
Urgent Field Safety Notice for PIEZOWAVE2 by Richard Wolf GmbH PDF, 1MB, File does not meet accessibility standards
Date: 12. December 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 42665/24
Urgent Field Safety Notice for MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP by Baxter Healthcare SA PDF, 408KB, File does not meet accessibility standards
Date: 12. December 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 37287/24
Urgent Field Safety Notice for Carestation 620 / 650 / 650c by Datex-Ohmeda, Inc. PDF, 251KB, File does not meet accessibility standards
Date: 12. December 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 43269/24
Urgent Field Safety Notice for redmount Space by hestomed GmbH PDF, 3MB, File does not meet accessibility standards
Date: 11. December 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 41643/24
Urgent Field Safety Notice for Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e by Maquet Critical Care AB PDF, 628KB, File does not meet accessibility standards
Date: 10. December 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 13178/24
Urgent Field Safety Notice for Revolution Maxima, Revolution Maxima Select by GE Hang Wei Medical Systems Co. Ltd PDF, 308KB, File does not meet accessibility standards
Date: 10. December 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - CT scanners
Reference 41056/24
Urgent Field Safety Notice for OMEGA Left Atrial Appendage (LAA) Occluder Device by Eclipse Medical Co. Ltd PDF, 131KB, File does not meet accessibility standards
Date: 10. December 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - cardiac surgery
Reference 41600/24
Urgent Field Safety Notice for UNID ROD by Medicrea International PDF, 1MB, File does not meet accessibility standards
Date: 10. December 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 42328/24
Urgent Field Safety Notice for Neck Segment, with suture holes, standard, uncemen by Waldemar Link GmbH & Co. KG PDF, 754KB, File does not meet accessibility standards
Date: 09. December 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 41608/24
Urgent Field Safety Notice for CADD-Solis Li-ion Rechargeable Battery Packs by Smiths Medical ASD, Inc. (Plymouth) is no. part of ICU Medical PDF, 253KB, File does not meet accessibility standards
Date: 09. December 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 32884/24
Urgent Field Safety Notice for 3M Transbond Self-Etching Primer by 3M Unitek Corporation PDF, 211KB, File does not meet accessibility standards
Date: 06. December 2024 Topics: Medical devices Type: Customer information
Product group Dental products - others
Reference 42014/24
Urgent Field Safety Notice for Horizon/McKesson Cardiology Hemo by Change Healthcare Canada Company PDF, 1MB, File does not meet accessibility standards
Date: 06. December 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 42619/24
Urgent Field Safety Notice for Sterile Percutaneous Reference Pin by Medtronic Navigation Inc. PDF, 872KB, File does not meet accessibility standards
Date: 06. December 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - navigation systems
Reference 42430/24
Urgent Field Safety Notice for UNO NERIA GUARD by Unomedical A/S PDF, 516KB, File does not meet accessibility standards
Date: 06. December 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 42410/24
Urgent Field Safety Notice for PDS II (polydioxanone) and MONOCRYL (poliglecaprone 25) sutures within Mölnlycke Procedure Trays by Mölnlycke Health Care AB PDF, 2MB, File does not meet accessibility standards
Date: 06. December 2024 Topics: Medical devices Type: Customer information
Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 42401/24
Urgent Field Safety Notice for Aeson Total Artificial Heart by CARMAT SA PDF, 206KB, File does not meet accessibility standards
Date: 04. December 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - artificial hearts
Reference 42073/24
Urgent Field Safety Notice for CO2 Incubator MCO-170AICD, MCO-170AICUVD/PHCbi/PHC Corporation by PHC Corporation - Ora PDF, 775KB, File does not meet accessibility standards
Date: 03. December 2024 Topics: Medical devices Type: Customer information
Product group Physical therapy - climatotherapy
Reference 08310/24
Urgent Field Safety Notice for Chairs F1 2000, F1 2000 E.g., F1 Neo, F1 Neo, E.g., F1 3000, F1 3000 E.g. by CAPRON PODOLOGIE PDF, 839KB, File does not meet accessibility standards
Date: 03. December 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - furnishings
Reference 19880/24
Urgent Field Safety Notice for Yukon® Chrome PC I Yukon® Choice PC by translumina GmbH PDF, 616KB, File does not meet accessibility standards
Date: 03. December 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 41143/24
Urgent Field Safety Notice for Gubisch Osteotom 20cm 2mm / Gubisch Osteotom 20cm 3mm by Medicon eG PDF, 212KB, File does not meet accessibility standards
Date: 02. December 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - general instruments
Reference 40750/24
Urgent Field Safety Notice for HeartStart Intrepid by Philips Goldway (Shenzhen) Industrial Inc. PDF, 355KB, File does not meet accessibility standards
Date: 02. December 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 22933/24
Urgent Field Safety Notice for PROGRIP by Sofradim (subsidiary of Covidien) PDF, 125KB, File does not meet accessibility standards
Date: 29. November 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 41815/24
Urgent Field Safety Notice for epoc NXS Host by Epocal, Inc. PDF, 256KB, File does not meet accessibility standards
Date: 29. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 41817/24
Urgent Field Safety Notice for Cartiva Synthetic Cartilage Implant by Cartiva, Inc. PDF, 879KB, File does not meet accessibility standards
Date: 29. November 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 40218/24
Urgent Field Safety Notice for MERLIN PROGRAMMER by S.. Jude Medical CRMD PDF, 123KB, File does not meet accessibility standards
Date: 29. November 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - defibrillators
Reference 40867/24
Urgent Field Safety Notice for Clinical Ultraschall-Gel 500 g by Ultragel Medical Kft PDF, 3MB, File does not meet accessibility standards
Date: 28. November 2024 Topics: Medical devices Type: Customer information
Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 40592/24
Urgent Field Safety Notice for Disposable Bipolar Pencil 25GA Straight by Kirwan Surgical Products LLC PDF, 242KB, File does not meet accessibility standards
Date: 28. November 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 40495/24
Urgent Field Safety Notice for Turbo Elite Laser Atherectomy Catheter by Spectranetics Corporation PDF, 951KB, File does not meet accessibility standards
Date: 28. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 41445/24
Urgent Field Safety Notice for BD FACSLyric Flow Cytometer by Becton, Dickinson and Company, BD Biosciences PDF, 277KB, File does not meet accessibility standards
Date: 28. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 41023/24
Urgent Field Safety Notice for BD BACTEC Blood Culture System, BD Phoenix M50 Automated Microbiology System, BD MAX System, BD COR System, BD EpiCenter Microbiology Data Management System & BD Synapsys Informatics Solution by Becton, Dickinson and Company PDF, 279KB, File does not meet accessibility standards
Date: 28. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 38239/24
Urgent Field Safety Notice for ROTEM sigma complete / ROTEM sigma complete + hep by Tem Innovations GmbH PDF, 640KB, File does not meet accessibility standards
Date: 27. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 40273/24
Urgent Field Safety Notice for Secondary Line FX with 0,2µ Filter, PVC-free by Fresenius Kabi AG PDF, 224KB, File does not meet accessibility standards
Date: 26. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 41083/24
Urgent Field Safety Notice for CGM CLINICAL Medication by CompuGroup Medical Deutschland AG PDF, 805KB, File does not meet accessibility standards
Date: 26. November 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 40903/24
Urgent Field Safety Notice for SynchroMed II Clinician Programmer Application by Medtronic Inc PDF, 193KB, File does not meet accessibility standards
Date: 25. November 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - drug pumps
Reference 40865/24
Urgent Field Safety Notice for OATS 2.0 Single-Use Set, 12 mm by Arthrex GmbH PDF, 1MB, File does not meet accessibility standards
Date: 22. November 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - bone surgery
Reference 38929/24
Urgent Field Safety Notice for BCL6 Breakapart Probe by Cytocell Ltd PDF, 902KB, File does not meet accessibility standards
Date: 22. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 40874/24
Urgent Field Safety Notice for Access Intact PTH (Reagent Pack) by Beckman Coulter, Inc. PDF, 2MB, File does not meet accessibility standards
Date: 22. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 40690/24
Urgent Field Safety Notice for Biofill infiltration cannula (single-use) by Human Med AG PDF, 3MB, File does not meet accessibility standards
Date: 22. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 40320/24
Urgent Field Safety Notice for EVair medical air compressor, Evair 03 by Datex-Ohmeda, Inc. PDF, 363KB, File does not meet accessibility standards
Date: 22. November 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 39910/23
Urgent Field Safety Notice for corpuls aed by GS Elektromedizinische Geräte G. Stemple GmbH PDF, 322KB, File does not meet accessibility standards
Date: 20. November 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 38536/24
Urgent Field Safety Notice for SOPHIE by Fritz Stephan GmbH PDF, 454KB, File does not meet accessibility standards
Date: 20. November 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 39327/24
Urgent Field Safety Notice for EZ Glide Aortic Cannula by Edwards Lifesciences LLC PDF, 504KB, File does not meet accessibility standards
Date: 20. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 40088/24
Urgent Field Safety Notice for HALYARD* PUREZERO* Limon* Nitrile Exam Gloves by O&M Halyard Inc. PDF, 361KB, File does not meet accessibility standards
Date: 20. November 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - auxiliary equipment
Reference 40223/24
Urgent Field Safety Notice for Hybrid Recon by Hermes Medical Solutions AB PDF, 1MB, File does not meet accessibility standards
Date: 20. November 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 38290/24
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 835KB, File does not meet accessibility standards
Date: 19. November 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 35587/24
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 1MB, File does not meet accessibility standards
Date: 19. November 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 35588/24
Urgent Field Safety Notice for Vitra 810 photocoagulator lasers by QUANTEL MEDICAL PDF, 489KB, File does not meet accessibility standards
Date: 18. November 2024 Topics: Medical devices Type: Customer information
Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 36668/24
Urgent Field Safety Notice for Olympus ETD PAA Premium by Miele & Cie. KG PDF, 740KB, File does not meet accessibility standards
Date: 18. November 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 34973/24
Urgent Field Safety Notice for OTESUS OR table column, stationary by Maquet GmbH PDF, 143KB, File does not meet accessibility standards
Date: 15. November 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 37590/24
Urgent Field Safety Notice for PROBP 3400, SPOT VISION SCREENER by Welch Allyn Inc PDF, 102KB, File does not meet accessibility standards
Date: 14. November 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electronic blood pressure monitor
Reference 13386/24
Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy PDF, 321KB, File does not meet accessibility standards
Date: 14. November 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 38017/24
Urgent Field Safety Notice for Zenition 50, Zenition 70 Systems by Philips Medical Systems Nederland B.V PDF, 1MB, File does not meet accessibility standards
Date: 14. November 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - mobile radiological diagnostic facilities
Reference 33948/24
Urgent Field Safety Notice for Jaco Robotic Arm by Kinova Inc. PDF, 124KB, File does not meet accessibility standards
Date: 14. November 2024 Topics: Medical devices Type: Customer information
Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 26799/24
Urgent Field Safety Notice for Thoraflex Hybrid by Vascutek Ltd PDF, 2MB, File does not meet accessibility standards
Date: 14. November 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 39731/24
Urgent Field Safety Notice for Allura Xper by Philips Medical Systems Nederland B.V. PDF, 497KB, File does not meet accessibility standards
Date: 14. November 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 39733/24
Urgent Field Safety Notice for JuggerLoc / ToggleLoc 2.9mm Drill Guide by Biomet Inc PDF, 1MB, File does not meet accessibility standards
Date: 13. November 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - bone surgery
Reference 38314/24
Urgent Field Safety Notice for Chameleon PTA Balloon Catheters by Covidien llc PDF, 1MB, File does not meet accessibility standards
Date: 12. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 32414/24
Urgent Field Safety Notice for YourLoops by DIABELOOP PDF, 194KB, File does not meet accessibility standards
Date: 12. November 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electric blood glucose meters
Reference 39180/24
Urgent Field Safety Notice for Proteus XR/a by GE Hualun Medical Systems Co Ltd PDF, 206KB, File does not meet accessibility standards
Date: 12. November 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - stationary radiological equipment
Reference 39465/24
Urgent Field Safety Notice for 501RP+ by Tosoh Corporation - Chuo-ku, Tokyo PDF, 115KB, File does not meet accessibility standards
Date: 12. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 31451/24
Urgent Field Safety Notice for Acurate neo2 and Prime Aortic Valve System by Boston Scientific Corporation Marlborough PDF, 467KB, File does not meet accessibility standards
Date: 12. November 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - cardiac surgery
Reference 38522/24
Urgent Field Safety Notice for BORA UP 2080 OP 230V 50/60 Hz by ATMOS MedizinTechnik GmbH & Co. KG PDF, 454KB, File does not meet accessibility standards
Date: 12. November 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 38741/24
Urgent Field Safety Notice for CORTRAK* 2 Enteral Access System (EAS) by Avanos Medical Inc PDF, 1MB, File does not meet accessibility standards
Date: 08. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 38248/24
Urgent Field Safety Notice for Acrobat-i and Acrobat SUV Stabilizer/Positioner by Maquet Cardiovascular PDF, 161KB, File does not meet accessibility standards
Date: 08. November 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 39138/24
Urgent Field Safety Notice for Atellica CI 1900 Analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 451KB, File does not meet accessibility standards
Date: 08. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 39134/24
Urgent Field Safety Notice for LINK MEGASYSTEM-C Elbow System Bearings by Link Italia S.p.A. PDF, 818KB, File does not meet accessibility standards
Date: 08. November 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 38360/24
Urgent Field Safety Notice for Local Run Manager DNA GenerateFASTQ Dx Module by Illumina, Inc. PDF, 1MB, File does not meet accessibility standards
Date: 07. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 38706/24
Urgent Field Safety Notice for TCM5 by Radiometer Medical ApS PDF, 178KB, File does not meet accessibility standards
Date: 07. November 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 36343/24
Urgent Field Safety Notice for EXTENDED LIFE PD TRANSFER SET, MINICAP EXTEND LIFE by Baxter Healthcare S. (Opfikon) PDF, 124KB, File does not meet accessibility standards
Date: 07. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 37121/24
Urgent Field Safety Notice for BIORAPTOR by Smith & Nephew, Inc., Endoscopy Division PDF, 168KB, File does not meet accessibility standards
Date: 07. November 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 38671/24
Urgent Field Safety Notice for MMI-AMTS-Service by Vidal MMI Germany GmbH PDF, 97KB, File does not meet accessibility standards
Date: 06. November 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 35834/24
Urgent Field Safety Notice for MINIject S by iSTAR Medical PDF, 301KB, File does not meet accessibility standards
Date: 06. November 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 30782/24
Urgent Field Safety Notice for 20/30 INDEFLATORTM, INDEFLATORTM Plus 30 and Priority Packs by Abbott Vascular, Santa Clara PDF, 197KB, File does not meet accessibility standards
Date: 06. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 38675/24
Urgent Field Safety Notice for Alinity c Proteins Standard by Biokit S. A. PDF, 182KB, File does not meet accessibility standards
Date: 06. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 21773/24
Urgent Field Safety Notice for AK 98 by Gambro Lundia AB PDF, 121KB, File does not meet accessibility standards
Date: 06. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 37714/24
Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 933KB, File does not meet accessibility standards
Date: 06. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 37449/24
Urgent Field Safety Notice for Atellica CH ß2-Microglobulin (B2M) by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 249KB, File does not meet accessibility standards
Date: 05. November 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 38488/24
Urgent Field Safety Notice for COBE 2991 Cell Processor System by Terumo BCT, Inc. PDF, 1MB, File does not meet accessibility standards
Date: 05. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 36502/24
Urgent Field Safety Notice for MST Duet® Reusable Handle for Single Use Heads by MicroSurgical Technology PDF, 103KB, File does not meet accessibility standards
Date: 05. November 2024 Topics: Medical devices Type: Customer information
Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 37908/24
Urgent Field Safety Notice for Selution SLR PTCA balloon catheter by MedAlliance CardioVascular SA PDF, 620KB, File does not meet accessibility standards
Date: 05. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 38052/24
Urgent Field Safety Notice for Lovo Disposable Kits by Fresenius Kabi AG PDF, 140KB, File does not meet accessibility standards
Date: 04. November 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 37106/24
Urgent Field Safety Notice for Tracheal Tube Reusable Introducer and Guides by ICU Medical Inc PDF, 643KB, File does not meet accessibility standards
Date: 04. November 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 37987/24
Urgent Field Safety Notice for Reusable and Single Use Flow Sensors by SLE Ltd. PDF, 119KB, File does not meet accessibility standards
Date: 04. November 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 36239/24
Urgent Field Safety Notice for 4Fr Single-Lumen PowerPICC Catheter (SOLO and no.-SOLO) by Bard Access Systems Division (BASD) PDF, 2MB, File does not meet accessibility standards
Date: 31. October 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 37768/24
Urgent Field Safety Notice for AMS 800 Urinary Control System by Boston Scientific Corporation Marlborough PDF, 341KB, File does not meet accessibility standards
Date: 31. October 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - special implants
Reference 37652/24
Urgent Field Safety Notice for VITROS Chemistry Products CRP Slides by QuidelOrtho (Ortho Clinical Diagnostics Inc) PDF, 332KB, File does not meet accessibility standards
Date: 31. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 37495/24
Urgent Field Safety Notice for safePICO A by Radiometer Medical ApS PDF, 177KB, File does not meet accessibility standards
Date: 31. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 35924/24
Urgent Field Safety Notice for ASSEMBLY, INTERNAL PADDLES, LP15, 3.0 by Physio-Control, Inc. PDF, 327KB, File does not meet accessibility standards
Date: 31. October 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 34319/24
Urgent Field Safety Notice for Axillary Insertion lntroducers and Introducer Kits by Oscor Inc. PDF, 926KB, File does not meet accessibility standards
Date: 31. October 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 33127/24
Urgent Field Safety Notice for NuViscTM Pro by Croma-Pharma GmbH PDF, 1MB, File does not meet accessibility standards
Date: 31. October 2024 Topics: Medical devices Type: Customer information
Product group ophthalmological technology - liquid media for ophthalmological purposes
Reference 30774/24
Urgent Field Safety Notice for Navitor/Navitor Titan Transcatheter Heart Valve by Abbott, Cardiovascular Division PDF, 161KB, File does not meet accessibility standards
Date: 30. October 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - cardiac surgery
Reference 36290/24
Urgent Field Safety Notice for Femoral ACL Marking Hook, AM Portal, 7 mm Offset by Arthrex Inc. PDF, 263KB, File does not meet accessibility standards
Date: 30. October 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - bone surgery
Reference 33715/24
Urgent Field Safety Notice for MEDUMAT Standard2, MEDUMAT Transport; withCO2 by WEINMANN Emergency Medical Technology GmbH + Co. KG PDF, 282KB, File does not meet accessibility standards
Date: 29. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 37246/24
Urgent Field Safety Notice for HScribe,Vision Express,Q-Stress,XScribe,RScribe by Welch Allyn Inc PDF, 254KB, File does not meet accessibility standards
Date: 29. October 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 36804/24
Urgent Field Safety Notice for NextSeq 550Dx / MiSeq Dx / NovaSeq 6000Dx by Illumina, Inc. PDF, 1MB, File does not meet accessibility standards
Date: 28. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 14389/24
Urgent Field Safety Notice for EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE by Olympus Medical Systems Corp. PDF, 679KB, File does not meet accessibility standards
Date: 28. October 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - endoscopes
Reference 36081/24
Urgent Field Safety Notice for Essenz Heart-Lung Machine with Software Version HLM.1.5 by LivaNova Italy PDF, 463KB, File does not meet accessibility standards
Date: 28. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 36042/24
Urgent Field Safety Notice for Olympus OFP-2 Flushing Pump by Olympus KeyMed (Medical & Industrieal Equipment Ltd.) PDF, 753KB, File does not meet accessibility standards
Date: 25. October 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - endoscopes
Reference 32169/24
Urgent Field Safety Notice for ILED 7 CEILING SINGLE ILED 7 MOBILE ILED 7 PENDANT by Baxter Medical Systems GmbH + Co. KG PDF, 105KB, File does not meet accessibility standards
Date: 25. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 20027/24
Urgent Field Safety Notice for SoKINOX / ServiNO / Monnal iNO by INOSYSTEMS PDF, 246KB, File does not meet accessibility standards
Date: 24. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 35790/24
Urgent Field Safety Notice for MiniMed 640G, 670G, 720G, 740G, 770G, 780G by Medtronic Minimed PDF, 126KB, File does not meet accessibility standards
Date: 24. October 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 35930/24
Urgent Field Safety Notice for Orchestra- und Pilot-Serie by Fresenius Kabi AG PDF, 136KB, File does not meet accessibility standards
Date: 23. October 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 35215/24
Urgent Field Safety Notice for Aggressive Cutter, sterile; Full Radius Resector, sterile; Aggr. Pro Line Shaver Blade, sterile; Round Burr, sterile; Aggressive Barrel Burr, sterile; Finish Barrel Burr, sterile; Semi Hooded Barrel Burr, sterile; Aggressive Barre by Karl Storz S. & Co KG PDF, 465KB, File does not meet accessibility standards
Date: 23. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 35787/24
Urgent Field Safety Notice for OPRACLEAN Mullbinde z.Tampon.m.Jodoform 1 cmx5 m by Lohmann & Rauscher GmbH & Co. KG PDF, 193KB, File does not meet accessibility standards
Date: 23. October 2024 Topics: Medical devices Type: Customer information
Product group Dressings / Pads - dressings
Reference 36724/24
Urgent Field Safety Notice for Centricity Universal Viewer Zero Footprint client by GE Healthcare PDF, 253KB, File does not meet accessibility standards
Date: 23. October 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - data processing facilities for image processing
Reference 36729/24
Urgent Field Safety Notice for Single Use Biopsy Valve by Olympus Medical Systems Corp. PDF, 427KB, File does not meet accessibility standards
Date: 22. October 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - endoscopes
Reference 34963/24
Urgent Field Safety Notice for Outer sheath, 22.5 Fr. by Olympus Winter & Ibe GmbH PDF, 182KB, File does not meet accessibility standards
Date: 21. October 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - endoscopes
Reference 35179/24
Urgent Field Safety Notice for mint Lesion by Mint Medical GmbH PDF, 220KB, File does not meet accessibility standards
Date: 21. October 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 36318/24
Urgent Field Safety Notice for VIDAS CK-MB by bioMérieux S. (Marcy- l'Etoile) PDF, 330KB, File does not meet accessibility standards
Date: 21. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 36263/24
Urgent Field Safety Notice for KayserBett EMMA, KayserBett IDA by KayserBetten GmbH & Co. KG PDF, 197KB, File does not meet accessibility standards
Date: 21. October 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - furnishings
Reference 35154/24
Urgent Field Safety Notice for MINISTAR 2 - Druckregler mit integrierten Flaschenventilen by GCE s.r.o. PDF, 755KB, File does not meet accessibility standards
Date: 18. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 35923/24
Urgent Field Safety Notice for Tandem Bipolar Hip System by Smith & Nephew, Inc., PDF, 290KB, File does not meet accessibility standards
Date: 18. October 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 36300/24
Urgent Field Safety Notice for HLM Tubing Set/HLM-Schlauchset by Maquet Cardiopulmonary GmbH PDF, 1MB, File does not meet accessibility standards
Date: 17. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 29972/24
Urgent Field Safety Notice for Precision Round, Distal Bend by Stryker Instruments-a division of Stryker Corp PDF, 298KB, File does not meet accessibility standards
Date: 17. October 2024 Topics: Medical devices Type: Customer information
Product group Medical instruments for use in humans - bone surgery
Reference 25263/24
Urgent Field Safety Notice for KayserBett OLAF by KayserBetten GmbH & Co. KG PDF, 202KB, File does not meet accessibility standards
Date: 17. October 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - furnishings
Reference 35155/24
Urgent Field Safety Notice for DR-XD 1000 / FDR Nano by FUJIFILM Corporation PDF, 245KB, File does not meet accessibility standards
Date: 17. October 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - mobile radiological diagnostic facilities
Reference 02101/24
Urgent Field Safety Notice for KayserBett OLAF by KayserBetten GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards
Date: 17. October 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - furnishings
Reference 35148/24
Urgent Field Safety Notice for Atlan Family by Drägerwerk AG & Co. KGaA PDF, 802KB, File does not meet accessibility standards
Date: 17. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 34122/24
Urgent Field Safety Notice for Philips VuePACS by Philips Medical Systems Nederland B.V. PDF, 1MB, File does not meet accessibility standards
Date: 17. October 2024 Topics: Medical devices Type: Customer information
Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 35949/24
Urgent Field Safety Notice for TruSystem 7000 (dV) by Baxter Medical Systems GmbH + Co. KG PDF, 129KB, File does not meet accessibility standards
Date: 17. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 34072/24
Urgent Field Safety Notice for Side Guards by Panthera AB PDF, 1MB, File does not meet accessibility standards
Date: 16. October 2024 Topics: Medical devices Type: Customer information
Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 34913/24
Urgent Field Safety Notice for EXOPULSE Charging Station by EXONEURAL NETWORK AB PDF, 353KB, File does not meet accessibility standards
Date: 16. October 2024 Topics: Medical devices Type: Customer information
Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 32800/24
Urgent Field Safety Notice for LINQ II Insertable Cardiac Monitor by Medtronic Inc PDF, 2MB, File does not meet accessibility standards
Date: 15. October 2024 Topics: Medical devices Type: Customer information
Product group Active implantable medical devices - programming and control equipment
Reference 33492/23
Urgent Field Safety Notice for Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda i.e. Warmer by Datex-Ohmeda, Inc PDF, 1MB, File does not meet accessibility standards
Date: 15. October 2024 Topics: Medical devices Type: Customer information
Product group Physical therapy - climatotherapy
Reference 35474/24
Urgent Field Safety Notice for UroPass Ureteral Access Sheath Set by Gyrus ACMI, Inc. PDF, 412KB, File does not meet accessibility standards
Date: 15. October 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 34124/24
Urgent Field Safety Notice for STA ECA II by Diagnostica Stago PDF, 220KB, File does not meet accessibility standards
Date: 15. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 34320/24
Urgent Field Safety Notice for POLARx & POLARx FIT Cryoablation Balloon Catheters by Boston Scientific Corporation Marlborough PDF, 412KB, File does not meet accessibility standards
Date: 15. October 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 35403/24
Urgent Field Safety Notice for Actim Partus Test by ActimOy PDF, 945KB, File does not meet accessibility standards
Date: 14. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 32895/24
Urgent Field Safety Notice for Quest Spectrum 3 Fluorescent Imaging System by Quest Medical Imaging b.v. PDF, 1MB, File does not meet accessibility standards
Date: 14. October 2024 Topics: Medical devices Type: Customer information
Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 33288/24
Urgent Field Safety Notice for Mentype AMLplexQS by Biotype Diagnostic GmbH PDF, 350KB, File does not meet accessibility standards
Date: 14. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 33653/24
Urgent Field Safety Notice for nal von minden Drug-Screen COC 300 Test by nal von minden GmbH PDF, 2MB, File does not meet accessibility standards
Date: 14. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 34302/24
Urgent Field Safety Notice for Q-Flow by Merivaara Corporation PDF, 424KB, File does not meet accessibility standards
Date: 14. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 35503/24
Urgent Field Safety Notice for NovaSeq 6000Dx by Illumina, Inc. PDF, 1MB, File does not meet accessibility standards
Date: 11. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 31889/24
Urgent Field Safety Notice for mylife App by SINOVO health solutions GmbH PDF, 139KB, File does not meet accessibility standards
Date: 11. October 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - medical apps
Reference 34565/24
Urgent Field Safety Notice for pH = 7.0 buffer solution for S. automated systems by RAL DIAGNOSTICS PDF, 2MB, File does not meet accessibility standards
Date: 11. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 07189/23
Urgent Field Safety Notice for IntelliVue MX400-550 by Philips Medizin Systeme Böblingen GmbH PDF, 543KB, File does not meet accessibility standards
Date: 11. October 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 30515/24
Urgent Field Safety Notice for Evolution Upgrade 3.0T, Ingenia 1.5T, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S. Ingenia Ambition X, Ingenia Elition S,Ingenia Elition X, MR 5300, MR 7700, SmartPath to dStream for 1.5T, SmartPath to dStream for XR and 3.0 by Philips Medical Systems Nederland B.V. PDF, 2MB, File does not meet accessibility standards
Date: 11. October 2024 Topics: Medical devices Type: Customer information
Product group Electromedical fields - equipment for MR tomography
Reference 29914/24
Urgent Field Safety Notice for Wound care dressings by Advanced Medical Solutions Limited PDF, 2MB, File does not meet accessibility standards
Date: 11. October 2024 Topics: Medical devices Type: Customer information
Product group Dressings / Pads - ointments and gels
Reference 36034/24
Urgent Field Safety Notice for EarlyCDT Lung Cancer Test Kit by Freenome Ltd PDF, 2MB, File does not meet accessibility standards
Date: 09. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 34825/24
Urgent Field Safety Notice for Untersuchungshandschuhe ZHPFN02 by Zhonghong Pulin Medical Products Co.,Ltd. PDF, 172KB, File does not meet accessibility standards
Date: 09. October 2024 Topics: Medical devices Type: Customer information
Product group General equipment for medical treatment - auxiliary equipment
Reference 31702/24
Urgent Field Safety Notice for IMMULITE® 2000 PSA by Siemens Healthcare Diagnostics Products Ltd. PDF, 190KB, File does not meet accessibility standards
Date: 09. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - immunological products
Reference 34797/24
Urgent Field Safety Notice for Nutrifix/Infusomat Space Line by B.Braun Melsungen AG PDF, 151KB, File does not meet accessibility standards
Date: 08. October 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 34544/24
Urgent Field Safety Notice for Dimension Vista Total Bilirubin Flex reagent cartridge by Siemens Healthcare Diagnostics, Inc PDF, 336KB, File does not meet accessibility standards
Date: 08. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 25656/24
Urgent Field Safety Notice for Jasper HPLC system by AB SCIEX Pte. Ltd. PDF, 909KB, File does not meet accessibility standards
Date: 08. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 33352/24
Urgent Field Safety Notice for Netzwerk-Isolator Cat.6A by EFB Elektronik GmbH PDF, 110KB, File does not meet accessibility standards
Date: 07. October 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 33054/24
Urgent Field Safety Notice for respons940 by DiaSys Diagnostic Systems GmbH PDF, 759KB, File does not meet accessibility standards
Date: 07. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 34587/24
Urgent Field Safety Notice for Tempus Pro by Remote Diagnostic Techologies Ltd PDF, 1MB, File does not meet accessibility standards
Date: 07. October 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 05161/23
Urgent Field Safety Notice for Stratus CS Acute Care D-dimer Calibrator by Siemens Healthcare Diagnostics Inc. Newark PDF, 431KB, File does not meet accessibility standards
Date: 07. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10063/23
Urgent Field Safety Notice for BiPAP A30, BiPAP A40 Ventilator by Respironics Inc. PDF, 741KB, File does not meet accessibility standards
Date: 07. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 10027/24
Urgent Field Safety Notice for Approach CTO & Approach Hydro S. Micro WireGuide by Cook Inc. PDF, 821KB, File does not meet accessibility standards
Date: 04. October 2024 Topics: Medical devices Type: Customer information
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 34171/24
Urgent Field Safety Notice for Nasopharyngeal Airway (6.0MM 10/BX+7.0MM 10/BX+8.0MM 10/BX+9.00MM 10/BX);15mm Double Swivel Connector 10/BX; Portex "orator" speaking valve for tracheostomy tube 2/CA; Thermovent 1200-15MM/22MM 20/BX by Smiths Medical ASD, lnc. PDF, 543KB, File does not meet accessibility standards
Date: 04. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 33870/24
Urgent Field Safety Notice for NEXUS / PDMS by NEXUS / DIS GmbH PDF, 93KB, File does not meet accessibility standards
Date: 04. October 2024 Topics: Medical devices Type: Customer information
Product group Medical data processing (software) - others
Reference 30952/24
Urgent Field Safety Notice for GX Assay Kit by Tosoh Corporation PDF, 231KB, File does not meet accessibility standards
Date: 03. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 12337/23
Urgent Field Safety Notice for ORTHO Vision & Vision Max Analyzer by Ortho Clinical Diagnostics Inc. PDF, 325KB, File does not meet accessibility standards
Date: 03. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 35164/23
Urgent Field Safety Notice for Codman Surgical Patties & Surgical Strips by Integra LifeSciences Mansfield PDF, 597KB, File does not meet accessibility standards
Date: 03. October 2024 Topics: Medical devices Type: Customer information
Product group Dressings / Pads - swabs, sponges, wipes, swabsticks
Reference 33652/24
Urgent Field Safety Notice for DARCO 7.0 HEADLESS SCREW 16X60 by Wright Medical Technology PDF, 431KB, File does not meet accessibility standards
Date: 03. October 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 32399/24
Urgent Field Safety Notice for SIL-40C X3 CL / SIL-40CXR CL by Shimadzu Corporation PDF, 97KB, File does not meet accessibility standards
Date: 02. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - microbiological products
Reference 30949/24
Urgent Field Safety Notice for SIL-20ACXR CL / SIL-30AC CL by Shimadzu Corporation PDF, 99KB, File does not meet accessibility standards
Date: 02. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - microbiological products
Reference 30957/24
Urgent Field Safety Notice for Leica Biosystems Cryostats by Leica Biosystems Nussloch GmbH PDF, 4MB, File does not meet accessibility standards
Date: 02. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 29440/24
Urgent Field Safety Notice for VITROS Chemistry Products CKMB Slides by Ortho-Clinical Diagnostics, Inc. PDF, 545KB, File does not meet accessibility standards
Date: 02. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 35250/23
Urgent Field Safety Notice for Medizym anti-GAD M by MEDIPAN GMBH PDF, 57KB, File does not meet accessibility standards
Date: 02. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 33069/24
Urgent Field Safety Notice for HemosIL AcuStar ADAMTS13-Activity Assay by Instrumentation Laboratory Co. PDF, 151KB, File does not meet accessibility standards
Date: 02. October 2024 Topics: Medical devices Type: Customer information
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 33256/24
Urgent Field Safety Notice for Cefaly Enhanced by CEFALY Technology PDF, 949KB, File does not meet accessibility standards
Date: 02. October 2024 Topics: Medical devices Type: Customer information
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 31690/24
Urgent Field Safety Notice for 10mm Flextube Resus Breathing Systems, Neopuff by Intersurgical Ltd. PDF, 1MB, File does not meet accessibility standards
Date: 02. October 2024 Topics: Medical devices Type: Customer information
Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 33931/24
Urgent Field Safety Notice for BAGUERA C / BAGUERA L by SPINEART S. (Plan-Les-Ouates) PDF, 325KB, File does not meet accessibility standards
Date: 01. October 2024 Topics: Medical devices Type: Customer information
Product group Non-active implants - bone surgery
Reference 31231/24