Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2024 – 31.03.2024 Німеччина

Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2024 – 31.03.2024

 

Німеччина

 

https://www.bfarm.de/EN/Medical-devices/Tasks/Risk-assessment-and-research/Field-corrective-actions/_node.html

https://www.bfarm.de/SharedDocs/Kundeninfos/DE/10/2022/29316-21_kundeninfo_de.pdf?__blob=publicationFile

Urgent Field Safety Notice for HeartMate 3 by Thoratec Corporation PDF, 111KB, File does not meet accessibility standards Date: 28. March 2024 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 08736/24

 

Urgent Field Safety Notice for Cortex Screw Stardrive by Oberdorf Synthes Produktions GmbH PDF, 2MB, File does not meet accessibility standards Date: 28. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 09988/24

 

Urgent Field Safety Notice for EZ2 Connect MDx by QIAGEN GmbH PDF, 273KB, File does not meet accessibility standards Date: 28. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 06291/24

 

Urgent Field Safety Notice for Philips IntelliVue Information Center iX by Philips Medizin Systeme Boblingen GmbH PDF, 611KB, File does not meet accessibility standards Date: 28. March 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 07585/24

 

Urgent Field Safety Notice for Atellica CH Iron3 by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 222KB, File does not meet accessibility standards Date: 28. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 08570/24

 

Urgent Field Safety Notice for Artis z.B./Q/Q.zen systems by Siemens Healthcare GmbH Advanced Therapies PDF, 800KB, File does not meet accessibility standards Date: 27. March 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 09137/24

 

Urgent Field Safety Notice for Rheo Knee / Rheo Knee XC by Össur hf. PDF, 472KB, File does not meet accessibility standards Date: 27. March 2024 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – prostheses (exoprostheses)
Reference 09594/24

 

Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG PDF, 2MB, File does not meet accessibility standards Date: 27. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 09750/24

 

Urgent Field Safety Notice for Mojo + Mojo2+iQ 2+Phantom 2 by Sleepnet Corporation PDF, 2MB, File does not meet accessibility standards Date: 27. March 2024 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – auxiliary equipment
Reference 07603/24

 

Urgent Field Safety Notice for Expo Angiographic Catheters by Boston Scientific Corporation Marlborough PDF, 1,012KB, File does not meet accessibility standards Date: 26. March 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 09148/24

 

Urgent Field Safety Notice for Working Element by Karl Storz S. & Co KG PDF, 270KB, File does not meet accessibility standards Date: 26. March 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 08981/24

 

Urgent Field Safety Notice for OCTOFLUX / ALGAFLEX / GUIDEWIRE INTRODUCER by PEROUSE MEDICAL (IVRY LE TEMPLE) PDF, 256KB, File does not meet accessibility standards Date: 26. March 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 09263/24

 

Urgent Field Safety Notice for Cardiosave Intraaortic Balloon Pump by Datascope Corp., Interventional Products Division PDF, 1,017KB, File does not meet accessibility standards Date: 26. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 34418/22

 

Urgent Field Safety Notice for TNI softFlow 50 by TNI medical AG PDF, 110KB, File does not meet accessibility standards Date: 25. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 08319/24

 

Urgent Field Safety Notice for TRIDENT II CLUSTERHOLE HA by Stryker Orthopaedics-Mahwah PDF, 251KB, File does not meet accessibility standards 25. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 07974/24

 

Urgent Field Safety Notice for Hugo RAS Surgeon Console by Covidien llc PDF, 275KB, File does not meet accessibility standards Date: 25. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 08948/24

 

Urgent Field Safety Notice for Equinoxe by EXACTECH, Inc. PDF, 1MB, File does not meet accessibility standards Date: 25. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 07765/24

 

Urgent Field Safety Notice for Hugo RAS Arm Cart Assembly by Covidien llc PDF, 649KB, File does not meet accessibility standards Date: 25. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 08947/24

 

Urgent Field Safety Notice for Astral 100, Astral 150 by ResMed Ltd. PDF, 609KB, File does not meet accessibility standards Date: 25. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 08339/24

 

Urgent Field Safety Notice for Hugo RAS Surgeon Console by Covidien llc PDF, 275KB, File does not meet accessibility standards Date: 22. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 08942/24

 

Urgent Field Safety Notice for Celex und Intelli-C EU by NRT-Nordisk Røntgen Teknik A/S PDF, 44KB, File does not meet accessibility standards Date: 22. March 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 08925/24

 

Urgent Field Safety Notice for BE-MECC 142000#NRP pack by Maquet Cardiopulmonary AG PDF, 2MB, File does not meet accessibility standards Date: 22. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 08299/24

 

Urgent Field Safety Notice for Hugo RAS Tower (120VAC/240VAC) by Covidien llc PDF, 274KB, File does not meet accessibility standards Date: 22. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 08943/24

 

Urgent Field Safety Notice for TotalView Chandelier for Eckardt cannula system.(23 gauge / 0.6 mm) by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. PDF, 373KB, File does not meet accessibility standards Date: 21. March 2024 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 08897/24

 

Urgent Field Safety Notice for Rhinomer isotonic 20ml by Laboratoire de la Mer PDF, 3MB, File does not meet accessibility standards Date: 21. March 2024 Topics: Medical devices Type: Customer information

Product group Physical therapy – inhalation therapy Reference 05006/24

 

Urgent Field Safety Notice for XFINE by MicroPort CRM PDF, 2MB, File does not meet accessibility standards Date: 21. March 2024 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – cardiac pacemakers
Reference 08481/24

 

Urgent Field Safety Notice for PERI-GUARD by Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.) PDF, 160KB, File does not meet accessibility standards Date: 21. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – cardiac surgery
Reference 06799/24

 

Urgent Field Safety Notice for Kimal Procedure Packs by Kimal Plc PDF, 1MB, File does not meet accessibility standards Date: 20. March 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 07203/21

 

Urgent Field Safety Notice for Batch KIT IRIS by Lettix bv PDF, 1MB, File does not meet accessibility standards Date: 20. March 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 15237/21

 

Urgent Field Safety Notice for Cervios chronOS wedge-shaped by Oberdorf Synthes Produktions GmbH PDF, 764KB, File does not meet accessibility standards Date: 19. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 07317/24

 

Urgent Field Safety Notice for Fabian HFO / HFOi by Acutronic Medical Systems AG PDF, 823KB, File does not meet accessibility standards Date: 19. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 06124/24

 

Urgent Field Safety Notice for MectaCem-X HV mit Gentamicin; MectaCem-X LV mit Gentamicin by Tecres S.p.A. PDF, 151KB, File does not meet accessibility standards Date: 19. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – materials for implants
Reference 08348/24

 

Urgent Field Safety Notice for Single Use Electrosurgical Knife by Olympus Medical Systems Corp. PDF, 389KB, File does not meet accessibility standards Date: 19. March 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 07614/24

 

Urgent Field Safety Notice for PERI-GUARD by Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.) PDF, 278KB, File does not meet accessibility standards Date: 19. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – cardiac surgery
Reference 05442/24

 

Urgent Field Safety Notice for HeartMate 3, HeartMate 2 by Thoratec Corporation PDF, 152KB, File does not meet accessibility standards Date: 19. March 2024 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 05369/24

 

Urgent Field Safety Notice for Epix Universal Clip Applier by Applied Medical Resources Corporation PDF, 466KB, File does not meet accessibility standards Date: 18. March 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 04214/24

 

Urgent Field Safety Notice for Palindrome by Covidien llc PDF, 823KB, File does not meet accessibility standards Date: 18. March 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 08463/24

 

Urgent Field Safety Notice for LIAISON BRAHMS PCT II GEN by DiaSorin Italia S.p.A. PDF, 184KB, File does not meet accessibility standards Date: 18. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 07973/24

 

Urgent Field Safety Notice for CUTISOFT COTTON TYPE 17 S by BSN medical GmbH PDF, 165KB, File does not meet accessibility standards Date: 18. March 2024 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – swabs, sponges, wipes, swabsticks
Reference 08192/24

 

Urgent Field Safety Notice for Access Substrate by Beckman Coulter, Inc. PDF, 1MB, File does not meet accessibility standards Date: 15. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 06386/24

 

Urgent Field Safety Notice for 2.5 ADAPTIVE II TriLock DistRad.Pl Vol L by Medartis AG PDF, 871KB, File does not meet accessibility standards Date: 15. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 05262/24

 

Urgent Field Safety Notice for ACUSON Juniper Diagnostic Ultrasound System by Siemens Medical Solutions USA, Inc., Ultrasound Division PDF, 133KB, File does not meet accessibility standards Date: 15. March 2024 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 06361/24

 

Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical Systems PDF, 378KB, File does not meet accessibility standards Date: 15. March 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 26657/23

 

Urgent Field Safety Notice for Promus PREMIER Select by Boston Scientific Corporation Marlborough PDF, 239KB, File does not meet accessibility standards Date: 13. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 07851/24

 

Urgent Field Safety Notice for Rhinomer Hypertonic 20ml by Laboratoire de la Mer PDF, 2MB, File does not meet accessibility standards 13. March 2024 Topics: Medical devices Type: Customer information

Product group Physical therapy – inhalation therapy
Reference 04998/24

 

Urgent Field Safety Notice for Abre Venous Self-expanding Stent System by Medtronic Inc PDF, 316KB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 07308/24

 

Urgent Field Safety Notice for AMICA-GEN by HS Hospital Service S.p.A. PDF, 2MB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 01410/24

 

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB PDF, 2MB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 06874/24

 

Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B.V. PDF, 267KB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 03856/24

 

Urgent Field Safety Notice for EVair medical air compressor, Evair 03 by Datex-Ohmeda, Inc. PDF, 314KB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 39910/23

 

Urgent Field Safety Notice for Dolphin Inflation Device/Caliber Inflation Device by PEROUSE MEDICAL (IVRY LE TEMPLE) PDF, 1MB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 26661/23

 

Urgent Field Safety Notice for DxA Automation System / DxA Aliquoter by Beckman Coulter Biomedical GmbH PDF, 427KB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 05422/24

 

Urgent Field Safety Notice for Quo-Lab A1C Test Kit / PocketChem HbA1Cc Test Kit by EKF-diagnostic GmbH PDF, 2MB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 07091/24

 

Urgent Field Safety Notice for ORTHO VISION Max BioVue Analyser by Ortho Clinical Diagnostics (Ortho) PDF, 525KB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 02569/21

 

Urgent Field Safety Notice for CarboFlex by ConvaTec Limited Deeside PDF, 2MB, File does not meet accessibility standards 12. March 2024 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 06829/24

 

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 282KB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 05515/24

 

Urgent Field Safety Notice for EcoFit® hip stem cementless lateralized sz. 13,75mm T-HA by implantcast GmbH PDF, 2MB, File does not meet accessibility standards Date: 12. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 36816/23

 

Urgent Field Safety Notice for Perseus A500 by Drägerwerk AG & Co. KGaA PDF, 306KB, File does not meet accessibility standards Date: 11. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 06774/24

 

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 418KB, File does not meet accessibility standards Date: 11. March 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 06073/24

 

Urgent Field Safety Notice for Disposable Biopsy Needle Kit by Elekta Solutions AB PDF, 132KB, File does not meet accessibility standards Date: 11. March 2024 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 07394/24

 

Urgent Field Safety Notice for G6PDH by DiaSys Diagnostic Systems GmbH PDF, 546KB, File does not meet accessibility standards Date: 11. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 06851/24

 

Urgent Field Safety Notice for AsperGenius Resistance Multiplex real-time PCR kit by PathoNostics B.V. PDF, 171KB, File does not meet accessibility standards Date: 08. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 00736/24

 

Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH PDF, 296KB, File does not meet accessibility standards Date: 08. March 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 06578/24

 

Urgent Field Safety Notice for VITROS Performance Verifiers I & II by QuidelOrtho (Ortho Clinical Diagnostics Inc) PDF, 309KB, File does not meet accessibility standards Date: 08. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 07092/24

 

Urgent Field Safety Notice for 1.2 K+-Draht, Lanzette, 150mm by Medartis AG PDF, 310KB, File does not meet accessibility standards 08. March 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 07571/24

 

Urgent Field Safety Notice for BÜHLMANN GanglioCombi MAG ELISA by Bühlmann Laboratories AG PDF, 841KB, File does not meet accessibility standards Date: 07. March 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 06922/24

 

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 633KB, File does not meet accessibility standards Date: 06. March 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 02845/24

 

Urgent Field Safety Notice for EVE IN; EVE TR; EVE NEO by Fritz Stephan GmbH PDF, 705KB, File does not meet accessibility standards Date: 05. March 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 07035/24

 

Urgent Field Safety Notice for FRÄSER ABWINKELBAR Ø 4MM by Richard Wolf GmbH PDF, 1MB, File does not meet accessibility standards Date: 05. March 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 06823/24

 

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 324KB, File does not meet accessibility standards Date: 05. March 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 01389/24

 

Urgent Field Safety Notice for ACUSON Maple/Maple Select ultrasound system by Siemens Medical Solutions USA, Inc. Ultrasound PDF, 980KB, File does not meet accessibility standards Date: 04. March 2024 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 06363/24

 

Urgent Field Safety Notice for NOVOSYN by B. Braun Surgical S.A. PDF, 876KB, File does not meet accessibility standards Date: 04. March 2024 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – surgical sutures, vascular loops etc.
Reference 06602/24

 

Urgent Field Safety Notice for Detachable EndoRetrieval Pouch by Unimax Medical Systems Inc. PDF, 259KB, File does not meet accessibility standards Date: 04. March 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 03527/24

 

Urgent Field Safety Notice for AGFA Digital Radiography X-Ray system DX-D 100 by Agfa HealthCare N.V. PDF, 269KB, File does not meet accessibility standards Date: 04. March 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 03999/24

 

Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH PDF, 314KB, File does not meet accessibility standards 01. March 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 06469/24

 

Urgent Field Safety Notice for NEXUS / PDMS by NEXUS / DIS GmbH PDF, 216KB, File does not meet accessibility standards Date: 01. March 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 06273/24

 

Urgent Field Safety Notice for Qstress 6, Xscribe 6 by Welch Allyn Inc PDF, 678KB, File does not meet accessibility standards Date: 01. March 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 38120/23

 

Urgent Field Safety Notice for Frame F2-01 by GE Healthcare Finland Oy PDF, 260KB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 28021/23

 

Urgent Field Safety Notice for Dilators/Coons Taper, Entuit Secure Adjustable Gastrointestinal Suture Anchor Sets, Chiba Biopsy Needles by Cook Incorporated PDF, 2MB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – cardiac/thorax surgery
Reference 06558/24

 

Urgent Field Safety Notice for Mölnlycke Procedure Trays & Detachable EndoRetrieval Pouch by Mölnlycke Health Care AB PDF, 2MB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 04992/24

 

Urgent Field Safety Notice for Digital mobile X-ray unit: MOVIX xx DREAM x series by Stephanix PDF, 306KB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – mobile radiological diagnostic facilities
Reference 03678/24

 

Urgent Field Safety Notice for Vanadis View Plate by Wallac Oy PDF, 899KB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – others
Reference 03465/24

 

Urgent Field Safety Notice for BD BodyGuard MicroSet by Caesarea Medical Electronics Ltd. PDF, 810KB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 06187/24

 

Urgent Field Safety Notice for CLARE/QUATUOREVO/LUCIS /CRISTAL/ARTIS PL Y/ARTISPLE by Cristalens Industrie PDF, 271KB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 39439/23

 

Urgent Field Safety Notice for Atellica IM Erythropoietin (EPO) Assay; ADVIA Centaur Erythropoietin (EPO) Assay; by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 257KB, File does not meet accessibility standards 29. February 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 02807/24

 

Urgent Field Safety Notice for Atellica CH Immunoglobulin M_2 (IgM_2) by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 441KB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 00133/24

 

Urgent Field Safety Notice for Alinity s System by Abbott Laboratories, Inc. PDF, 171KB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 02198/24

 

Urgent Field Safety Notice for GOT Multi SF6 GOT-007-00 by AL.CHI.MI.A. S.R.L. PDF, 491KB, File does not meet accessibility standards Date: 29. February 2024 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – liquid media for ophthalmological purposes
Reference 33125/23

 

Urgent Field Safety Notice for Neonatal ArcticGel Pads for Arctic Sun by Medivance, Inc. PDF, 449KB, File does not meet accessibility standards Date: 28. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 05194/24

 

Urgent Field Safety Notice for ACUSON Redwood by Siemens Medical Solutions USA, Inc., Ultrasound Division PDF, 1MB, File does not meet accessibility standards Date: 28. February 2024 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 06362/24

 

Urgent Field Safety Notice for ETT Set with cuffed Murphy ETT intubation by Guangzhou AMK Medical Equipment Co., Ltd. PDF, 2MB, File does not meet accessibility standards Date: 28. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 05722/24

 

Urgent Field Safety Notice for Filter/HME TwinStar by Drägerwerk AG & Co. KGaA PDF, 655KB, File does not meet accessibility standards Date: 28. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 05575/24

 

Urgent Field Safety Notice for Atellica UAS 800 Analyzer, Atellica 1500 Automated Urinalysis System by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 218KB, File does not meet accessibility standards Date: 27. February 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 03006/24

 

Urgent Field Safety Notice for Alinity s System by Abbott Laboratories, Inc. PDF, 193KB, File does not meet accessibility standards Date: 27. February 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 01708/24

 

Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter Inc. PDF, 2MB, File does not meet accessibility standards Date: 27. February 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 00197/24

 

Urgent Field Safety Notice for ARCHITECT S.A. Myoglobin Reagent Kit by Abbott Laboratories (Abbott Park) PDF, 166KB, File does not meet accessibility standards Date: 26. February 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 06053/24

 

Urgent Field Safety Notice for NEXUS / PDMS by NEXUS / DIS GmbH PDF, 84KB, File does not meet accessibility standards Date: 26. February 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 04213/24

 

Urgent Field Safety Notice for AltoSa-XL-Gemini Balloon Catheter by Andratec GmbH PDF, 586KB, File does not meet accessibility standards Date: 23. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 05868/24

 

Urgent Field Safety Notice for Philips Intera, Achieva, Ingenia CX by PHILIPS HEALTHCARE FRANCE PDF, 374KB, File does not meet accessibility standards Date: 23. February 2024 Topics: Medical devices Type: Customer information

Product group Electromedical fields – equipment for MR tomography
Reference 00718/24

 

Urgent Field Safety Notice for Bluephase Style by Ivoclar Vivadent AG PDF, 389KB, File does not meet accessibility standards Date: 22. February 2024 Topics: Medical devices Type: Customer information

Product group Dental products – equipment
Reference 04581/24

 

Urgent Field Safety Notice for EVA NEXUS by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. PDF, 352KB, File does not meet accessibility standards Date: 22. February 2024 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 05444/24

 

Urgent Field Safety Notice for THUNDERBEAT by Olympus Medical Systems Corp. PDF, 340KB, File does not meet accessibility standards Date: 22. February 2024 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic therapeutic equipment
Reference 28691/23

 

Urgent Field Safety Notice for HIP PRESERVATION SYSTEM SIGNATURE SERIES by ConMed Corporation PDF, 766KB, File does not meet accessibility standards Date: 22. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 04887/24

 

Urgent Field Safety Notice for ISLEEVE 14F by Boston Scientific Corporation Marlborough PDF, 136KB, File does not meet accessibility standards Date: 22. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 05570/24

 

Urgent Field Safety Notice for Setpack Sterile surgical jersey / Kitpack w jersey by Lohmann und Rauscher GmbH & Co. KG PDF, 262KB, File does not meet accessibility standards Date: 22. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 04736/24

 

Urgent Field Safety Notice for s.a..safe Catheter Extension Luer-Lock variants by Fresenius Medical Care AG & Co. KGaA PDF, 157KB, File does not meet accessibility standards Date: 20. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 05247/24

Urgent Field Safety Notice for Aquilion Serve by Canon Medical Systems Corporation PDF, 390KB, File does not meet accessibility standards Date: 20. February 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 05187/24

 

Urgent Field Safety Notice for Epsylar Percutaneous Introducer Sheath by optimed Medizinische Instrumente GmbH PDF, 2MB, File does not meet accessibility standards Date: 16. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 03147/24

 

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 423KB, File does not meet accessibility standards Date: 15. February 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 04025/24

 

Urgent Field Safety Notice for Experience Mini Metal Rhodium by GC Orthodontics Europe GmbH PDF, 2MB, File does not meet accessibility standards Date: 15. February 2024 Topics: Medical devices Type: Customer information

Product group Dental products – orthodontic equipment
Reference 02413/24

 

Urgent Field Safety Notice for POLARSHEATH by Boston Scientific Corporation Marlborough PDF, 303KB, File does not meet accessibility standards Date: 15. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 04604/24

 

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 311KB, File does not meet accessibility standards Date: 15. February 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 02943/24

 

Urgent Field Safety Notice for ExcelsiusGPS by Globus Medical, Inc. PDF, 2MB, File does not meet accessibility standards Date: 15. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 03537/24

 

Urgent Field Safety Notice for Radiel Artery Catheterization Set by Arrow International Inc. US PDF, 1MB, File does not meet accessibility standards Date: 14. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 04549/24

 

Urgent Field Safety Notice for Foliodress Gown by WINNER MEDICAL Co., Ltd. (CY) PDF, 1MB, File does not meet accessibility standards Date: 14. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 03842/24

 

Urgent Field Safety Notice for Tensive Conductive Adhesive Gel by Parker Laboratories, Inc. PDF, 225KB, File does not meet accessibility standards Date: 14. February 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 01606/24

 

Urgent Field Safety Notice for ExcelsiusGPS by Globus Medical, Inc. PDF, 2MB, File does not meet accessibility standards Date: 13. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 01607/24

 

Urgent Field Safety Notice for SOLTIVE SuperPulsed Laser System by Gyrus ACMI, Inc. PDF, 183KB, File does not meet accessibility standards Date: 13. February 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – laser technology
Reference 03185/24

 

Urgent Field Safety Notice for SeQuent Please Neo by B. Braun Melsungen AG PDF, 2MB, File does not meet accessibility standards Date: 09. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 33775/23

 

Urgent Field Safety Notice for BD Manifolds with Stopcocks by Sendal S.L. PDF, 901KB, File does not meet accessibility standards Date: 09. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 04008/24

 

Urgent Field Safety Notice for DLP Vessel Cannula by Medtronic Inc PDF, 1MB, File does not meet accessibility standards Date: 09. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 03937/24

Urgent Field Safety Notice for PK Cutting Forceps, 5MM, 33CM by Gyrus ACMI – Olympus – OSTA PDF, 209KB, File does not meet accessibility standards Date: 08. February 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 00890/24

 

Urgent Field Safety Notice for BS 3/8×3/32 L1.7 by Maquet Cardiopulmonary GmbH PDF, 5MB, File does not meet accessibility standards Date: 07. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 02177/24

 

Urgent Field Safety Notice for Cerebase DA Guide Sheath by Medos International SARL PDF, 2MB, File does not meet accessibility standards Date: 07. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 03541/24

 

Urgent Field Safety Notice for Original Perfusor Line by B. Braun Melsungen AG PDF, 173KB, File does not meet accessibility standards Date: 06. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 03649/24

 

Urgent Field Safety Notice for Accessory Sets, Syringe: Closed System Product Sampling by Origen Biomedical PDF, 51KB, File does not meet accessibility standards Date: 06. February 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Reference 39378/23

 

Urgent Field Safety Notice for Care Plus, Care Plus Model 1000, 2000, 3000 und 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator und Lullaby XP by WIPRO GE Healthcare Private Ltd. PDF, 476KB, File does not meet accessibility standards Date: 05. February 2024 Topics: Medical devices Type: Customer information

Product group Physical therapy – climatotherapy
Reference 03497/24

 

Urgent Field Safety Notice for Recugel by Bausch & Lomb GmbH PDF, 428KB, File does not meet accessibility standards Date: 05. February 2024 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – liquid media for ophthalmological purposes
Reference 01093/24

Urgent Field Safety Notice for HRIS ACET CUP CUT TIP by Stryker Joint Replacement PDF, 254KB, File does not meet accessibility standards Date: 05. February 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 00577/24

 

Urgent Field Safety Notice for ExcelsiusGPS by Globus Medical, Inc. PDF, 2MB, File does not meet accessibility standards Date: 01. February 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 02106/24

 

Urgent Field Safety Notice for IC9-RS by GE Healthcare Austria GmbH & Co OG PDF, 371KB, File does not meet accessibility standards Date: 31. January 2024 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 02771/24

 

Urgent Field Safety Notice for DR-XD 1000 / FDR Nano by FUJIFILM Corporation PDF, 604KB, File does not meet accessibility standards Date: 31. January 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – mobile radiological diagnostic facilities
Reference 02101/24

 

Urgent Field Safety Notice for S-12 Handpiece by W&H Dentalwerk Bürmoos GmbH PDF, 839KB, File does not meet accessibility standards Date: 29. January 2024 Topics: Medical devices Type: Customer information

Product group Dental products – equipment
Reference 01690/24

 

Urgent Field Safety Notice for Philips Allura Xper, Allura Centron and Azurion by Philips Medical Systems Nederland B.V. PDF, 1MB, File does not meet accessibility standards Date: 29. January 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 00026/24

 

Urgent Field Safety Notice for Duet External Drainage and Monitoring System; Duet External Drainage and Monitoring System, Interlink Iniection Sites, Ventricular Catheter; Duet External Drainage and Monitoring System, Smart by Medtronic Inc PDF, 219KB, File does not meet accessibility standards Date: 29. January 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 02609/24

Urgent Field Safety Notice for INFX-8000C, INFX-8000F, INFX-8000V by Canon Medical Systems Corporation PDF, 477KB, File does not meet accessibility standards Date: 29. January 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 01863/24

 

Urgent Field Safety Notice for GLDH FS DGKC by DiaSys Deutschland Vertriebs-GmbH PDF, 283KB, File does not meet accessibility standards Date: 26. January 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 37289/23

 

Urgent Field Safety Notice for TFNA Femoral Nail, VA-LCP Clavicle Plate, OPAL Intervertebral Cage by Oberdorf Synthes Produktions GmbH PDF, 492KB, File does not meet accessibility standards Date: 26. January 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 02419/24

 

Urgent Field Safety Notice for BiMobile Dual Mobility System, Liner by Waldemar Link GmbH & Co. KG PDF, 3MB, File does not meet accessibility standards Date: 26. January 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 02178/24

 

Urgent Field Safety Notice for RiaRSR VGCC Ab by RSR Limited PDF, 835KB, File does not meet accessibility standards Date: 25. January 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 02345/24

 

Urgent Field Safety Notice for Surgilon Braided Nylon; Sofsilk Wax/silicone Coated Braided Silk by Covidien llc PDF, 1MB, File does not meet accessibility standards Date: 25. January 2024 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – surgical sutures, vascular loops etc.
Reference 39201/23

 

Urgent Field Safety Notice for Centricity High Acuity (CHA) C.C and Anesthesia by GE Healthcare Finland Oy PDF, 198KB, File does not meet accessibility standards Date: 23. January 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 00856/24

Urgent Field Safety Notice for Untersuchungs- und OP-Leuchten by MAQUET SAS PDF, 413KB, File does not meet accessibility standards Date: 23. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 01348/24

 

Urgent Field Safety Notice for SAFEWARM by Istanbul Medikal Ltd. St.. PDF, 777KB, File does not meet accessibility standards Date: 23. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 36651/23

 

Urgent Field Safety Notice for Urea by Thermo Fisher Scientific Oy PDF, 2MB, File does not meet accessibility standards Date: 22. January 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 00306/24

 

Urgent Field Safety Notice for SERVO-n by Maquet Critical Care AB PDF, 529KB, File does not meet accessibility standards Date: 22. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 01318/24

 

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 282KB, File does not meet accessibility standards Date: 22. January 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 01104/24

 

Urgent Field Safety Notice for Olympus ETD PAA Premium by Miele & Cie. KG PDF, 189KB, File does not meet accessibility standards Date: 22. January 2024 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 01091/24

 

Urgent Field Safety Notice for 3 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM) by Zimmer Inc. PDF, 792KB, File does not meet accessibility standards Date: 22. January 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 01053/24

 

Urgent Field Safety Notice for HF-resection electrode by Olympus Winter & Ibe GmbH PDF, 133KB, File does not meet accessibility standards Date: 22. January 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 17365/23

 

Urgent Field Safety Notice for Navigation Marker Spheres by Neuromedex GmbH PDF, 182KB, File does not meet accessibility standards Date: 19. January 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – special surgical instruments
Reference 01585/24

 

Urgent Field Safety Notice for Cranial Kit – No Drugs by INTEGRA Pain management PDF, 401KB, File does not meet accessibility standards Date: 19. January 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – neurosurgery
Reference 01688/24

 

Urgent Field Safety Notice for BodyGuard infusion pumps by Caesarea Medical Electronics Ltd. PDF, 362KB, File does not meet accessibility standards Date: 19. January 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 36281/23

 

Urgent Field Safety Notice for PHYSICA TT TIBIAL PLATES by LIMACORPORATE S.P.A. PDF, 890KB, File does not meet accessibility standards Date: 17. January 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 00434/24

 

Urgent Field Safety Notice for Drainage bag by Ningbo Luke Medical Devices Co PDF, 1MB, File does not meet accessibility standards 17. January 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 01034/24

 

Urgent Field Safety Notice for 3M Surgical / 3M Specialty Clipper Blades by 3M Health Care PDF, 284KB, File does not meet accessibility standards Date: 17. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 01200/24

 

Urgent Field Safety Notice for mint Lesion by Mint Medical GmbH PDF, 1MB, File does not meet accessibility standards Date: 17. January 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 01313/24

Urgent Field Safety Notice for Figulla Flex II ASD by Occlutech GmbH PDF, 631KB, File does not meet accessibility standards Date: 16. January 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – cardiac surgery
Reference 01353/24

 

Urgent Field Safety Notice for SOLTIVE Single-use Laser Fibers by Gyrus ACMI Inc. PDF, 205KB, File does not meet accessibility standards Date: 15. January 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – laser technology
Reference 39789/23

 

Urgent Field Safety Notice for Optima Coil System, Prestige Coil System by BALT USA LLC PDF, 1MB, File does not meet accessibility standards Date: 15. January 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 00439/24

 

Urgent Field Safety Notice for TFL Fiber Cleaver, TFL Fiber Stripper/ Olympus by Gyrus ACMI, Inc. PDF, 252KB, File does not meet accessibility standards Date: 15. January 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – laser technology
Reference 39908/23

 

Urgent Field Safety Notice for DORC Directional Laser Probe by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. PDF, 422KB, File does not meet accessibility standards Date: 15. January 2024 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 00433/24

 

Urgent Field Safety Notice for SINGLE USE DISTAL COVER by Olympus Medical Systems Corp. PDF, 384KB, File does not meet accessibility standards Date: 15. January 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 38389/23

 

Urgent Field Safety Notice for DynaMesh-IPST by FEG Textiltechnik Forschung- und Entwicklungsgesellschaft mbH PDF, 714KB, File does not meet accessibility standards Date: 15. January 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 00791/24

 

Urgent Field Safety Notice for Altair and Roomer S by Human Care HC Sweden AB PDF, 484KB, File does not meet accessibility standards Date: 12. January 2024 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 00568/24

 

Urgent Field Safety Notice for FiberTak® DX Suture Anchor, Double-Loaded With 0.9 by Arthrex INC PDF, 308KB, File does not meet accessibility standards Date: 12. January 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 00723/24

 

Urgent Field Safety Notice for Manujet III including Jet-Ventilation Catheters by VBM Medizintechnik GmbH PDF, 308KB, File does not meet accessibility standards Date: 12. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 36081/23

 

Urgent Field Safety Notice for Perceval PLUS Sutureless Aortic Heart Valve by Corcym S.r.l. (also trading as Sorin Group Italia S.r.l) PDF, 2MB, File does not meet accessibility standards Date: 11. January 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – cardiac surgery
Reference 39644/23

 

Urgent Field Safety Notice for INVOS reusable sensor cable for PM7100 / INVOS Reusable Infant Sensor Adapter Cable for PM7100 by Covidien llc PDF, 3MB, File does not meet accessibility standards Date: 11. January 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 00825/24

 

Urgent Field Safety Notice for RADIA Effector Universal Needle Holder by Asensus Surgical Italia S.r.l. PDF, 1MB, File does not meet accessibility standards Date: 11. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 36562/23

 

Urgent Field Safety Notice for VICRYL Polyglactin 910 Suture by Ethicon, Inc. PDF, 1MB, File does not meet accessibility standards Date: 11. January 2024 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – surgical sutures, vascular loops etc.
Reference 38783/23

Urgent Field Safety Notice for iQ200 Series, DxU 850m and 840m Iris Analyzers by Beckman Coulter Inc. PDF, 1MB, File does not meet accessibility standards Date: 11. January 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 39642/23

 

Urgent Field Safety Notice for Alef, Til, Conix by Medical Systems and Devices International Ltd. PDF, 450KB, File does not meet accessibility standards Date: 11. January 2024 Topics: Medical devices Type: Customer information

Product group Dental products – dental implants
Reference 00100/24

 

Urgent Field Safety Notice for Venue Go by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC PDF, 962KB, File does not meet accessibility standards Date: 10. January 2024 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 29889/23

 

Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG PDF, 2MB, File does not meet accessibility standards 09. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 25523/23

 

Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG PDF, 4MB, File does not meet accessibility standards Date: 09. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 29773/23

 

Urgent Field Safety Notice for SEKUSEPT Pulver by Ecolab Deutschland GmbH PDF, 1MB, File does not meet accessibility standards Date: 09. January 2024 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 00250/24

 

Urgent Field Safety Notice for Achieva 1.5T: 781178, 781196, 781296 Achieva 1.5T Conversion: 781283 Achieva 3.0T: 781177 Ingenia Ambition X: 782109 Intera 1.5T: 781195 SmartPath to dStream for 1.5T: 781260, 782112 by Philips Medical Systems Nederland B.V. PDF, 447KB, File does not meet accessibility standards Date: 09. January 2024 Topics: Medical devices Type: Customer information

Product group Electromedical fields – equipment for MR tomography
Reference 39885/23

Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG PDF, 985KB, File does not meet accessibility standards Date: 08. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 32156/23

 

Urgent Field Safety Notice for Incidin Rapid by Ecolab Deutschland GmbH PDF, 1MB, File does not meet accessibility standards Date: 05. January 2024 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 38544/23

 

Urgent Field Safety Notice for Haltearm by Rebstock Instruments GmbH PDF, 1MB, File does not meet accessibility standards Date: 05. January 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 39551/23

 

Urgent Field Safety Notice for da Vinci Xi and da Vinci X Surgical System by Intuitive Surgical, Inc PDF, 2MB, File does not meet accessibility standards Date: 04. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 07009/23

 

Urgent Field Safety Notice for Suprasorb A+Ag Antimicrobial Ca-Alginate Dressing by Lohmann und Rauscher GmbH & Co. KG PDF, 422KB, File does not meet accessibility standards Date: 04. January 2024 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 00136/24

 

Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG PDF, 1MB, File does not meet accessibility standards Date: 04. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 32157/23

 

Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG PDF, 5MB, File does not meet accessibility standards Date: 04. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 24727/23

 

Urgent Field Safety Notice for Tubing Sets with Hemoconcentrator by Maquet Cardiopulmonary GmbH PDF, 2MB, File does not meet accessibility standards Date: 04. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 39389/23

 

Urgent Field Safety Notice for CGM CLINICAL Medication by CompuGroup Medical Deutschland AG PDF, 292KB, File does not meet accessibility standards Date: 04. January 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 39347/23

 

Urgent Field Safety Notice for neuromate stereotactic system by RENISHAW mayfield PDF, 3MB, File does not meet accessibility standards Date: 02. January 2024 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 37665/23

 

Urgent Field Safety Notice for InSpace system by Orthospace Ltd. PDF, 420KB, File does not meet accessibility standards Date: 02. January 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants – other implants
Reference 39461/23

 

Urgent Field Safety Notice for Luminos Fusion, Luminos RF Classic, Luminos Select, Multix Fusion, Multix Fusion Max, MULTIX Impact, MULTIX Impact C mit Halterung für Kindermulde am Rasterwandgerät by Siemens Shanghai Medical Equipment Ltd. (SSME) PDF, 720KB, File does not meet accessibility standards Date: 02. January 2024 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 39573/23

 

Urgent Field Safety Notice for Secufill by Medex SAS PDF, 3MB, File does not meet accessibility standards Date: 02. January 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 38779/23

 

Urgent Field Safety Notice for Custom Procedure Trays (CPTs) including Bacterial Filter Slime Line by ArcRoyal uc. an Owens and Minor Company PDF, 833KB, File does not meet accessibility standards Date: 02. January 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – filters
Reference 37096/23

 

Urgent Field Safety Notice for HLS Set Advanced 5.0, HLS Set Advanced 7.0, by Maquet Cardiopulmonary GmbH PDF, 9MB, File does not meet accessibility standards Date: 02. January 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 39256/23

 

Urgent Field Safety Notice for Benefusion nSP by Shenzhen Shenke Medical Instrument Technical Development Co. , Ltd. PDF, 298KB, File does not meet accessibility standards Date: 02. January 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 39643/23