Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2022 – 30.09.2022

Опубліковано 18.10.2022 о 15:34

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

30. September 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 25991/22

29. September 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 25323/22

Urgent Field Safety Notice for avatera by avateramedical GmbH PDF, 270KB, File does not meet accessibility standards Date: 28. September 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 25177/22

Urgent Field Safety Notice for Nobel Biocare N1 TiUltra TCC NP 3.5x13mm by Nobel Biocare AB PDF, 476KB, File does not meet accessibility standards Date: 28. September 2022 Topics: Medical devices Type: Customer information

Product group Dental products – dental implants
Reference 19079/22

Urgent Field Safety Notice for ZytoChem-Plus HRP Kit, Broad Spectrum by Zytomed Systems GmbH PDF, 305KB, File does not meet accessibility standards Date: 26. September 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 24009/22

Urgent Field Safety Notice for Check-Flo Performer Introducer by Cook Incorporated PDF, 553KB, File does not meet accessibility standards Date: 26. September 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 25630/22

Urgent Field Safety Notice for FertiCult Mineral Oil by FertiPro NV PDF, 1MB, File does not meet accessibility standards Date: 22. September 2022 Topics: Medical devices Type: Customer information

Product group Physical therapy – others
Reference 25023/22

Urgent Field Safety Notice for 2105489-003 AMSORB PLUS PREFILLED G-CAN® 1.0L by Armstrong Medical Ltd. PDF, 200KB, File does not meet accessibility standards Date: 22. September 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 24748/22

Urgent Field Safety Notice for Vanta LT Clinician Programmer Application by Medtronic Inc PDF, 320KB, File does not meet accessibility standards Date: 22. September 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – programming and control equipment
Reference 18975/22

Urgent Field Safety Notice for various Wire Guides, Vinyl Connecting Tubes by Cook Incorporated PDF, 910KB, File does not meet accessibility standards Date: 22. September 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 21038/22

Urgent Field Safety Notice for Unity CS Inserts by Corin Medical Ltd. PDF, 268KB, File does not meet accessibility standards Date: 21. September 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 19263/22

21. September 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 24859/22

Urgent Field Safety Notice for GM501 Mineral Oil by Gynemed GmbH & Co. KG PDF, 157KB, File does not meet accessibility standards Date: 21. September 2022 Topics: Medical devices Type: Customer information

Product group Physical therapy – others
Reference 25012/22

Urgent Field Safety Notice for Vanta LT Clinician Programmer Application by Medtronic Inc PDF, 305KB, File does not meet accessibility standards Date: 20. September 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – programming and control equipment
Reference 18976/22

Urgent Field Safety Notice for GELITA TUFT-IT by GELITA MEDICAL GmbH PDF, 1MB, File does not meet accessibility standards Date: 14. September 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – ointments and gels
Reference 23795/22

Urgent Field Safety Notice for Avance CS2, Avance CS2 Pro, Aisys CS2 by Datex-Ohmeda, Inc. PDF, 229KB, File does not meet accessibility standards Date: 13. September 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 23105/22

Urgent Field Safety Notice for Teledyne Oxygen Sensor R-22A by Hamilton Medical AG PDF, 865KB, File does not meet accessibility standards Date: 13. September 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 23524/22

Urgent Field Safety Notice for Extremity Pack by Medline International France SAS PDF, 532KB, File does not meet accessibility standards Date: 13. September 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 21715/22

Urgent Field Safety Notice for HELIX DRILL D.3,5MM by Lima Corporate S.p.A. PDF, 485KB, File does not meet accessibility standards Date: 13. September 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 23101/22

Urgent Field Safety Notice for Barco by Barco PDF, 144KB, File does not meet accessibility standards Date: 12. September 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 18665/22

Urgent Field Safety Notice for MitraClip G4 Clip Delivery System, MitraClip NTR/XTR Clip Delivery System, TriClip NT/XT Clip Delivery System, and TriClip G4 Clip Delivery System by Abbott Vascular PDF, 431KB, File does not meet accessibility standards Date: 12. September 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – cardiac surgery
Reference 23345/22

12. September 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 23149/22

Urgent Field Safety Notice for Puritan Bennett 520 Ventilator, Puritan Bennett 56 by Covidien llc PDF, 906KB, File does not meet accessibility standards Date: 12. September 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 22285/22

Urgent Field Safety Notice for elisa 600; elisa 800; elisa 800 VIT by Salvia medical GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 09. September 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 22931/22

Urgent Field Safety Notice for Amara View Minimal Contact Full-Face Mask (Full Face Mask); DreamWear Full Face Mask (Full Face Mask); DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask); Wisp Nasal Mask (Nasal Mask); Wisp Youth Nasal Mask (Nasal Mask); by Respironics, Inc. Pittsburgh PDF, 332KB, File does not meet accessibility standards Date: 09. September 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 20617/22

Urgent Field Safety Notice for Avance CS2, CS2 Pro by GE Healthcare Technologies (Datex Ohmeda) PDF, 231KB, File does not meet accessibility standards Date: 08. September 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 20198/22

Urgent Field Safety Notice for Barco by Barco PDF, 157KB, File does not meet accessibility standards Date: 08. September 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 18651/22

Urgent Field Safety Notice for BiPAP A30, BiPAP A40 Ventilator by Respironics Inc. PDF, 377KB, File does not meet accessibility standards Date: 06. September 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 19853/22

Urgent Field Safety Notice for ProteusPLUS, ProteusONE by IBA (Ion Beam Applications) PDF, 161KB, File does not meet accessibility standards Date: 06. September 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – nuclear medical therapeutic equipment
Reference 03543/22

Urgent Field Safety Notice for Flocare DirectPEG by BS Medical Tech Industry PDF, 2MB, File does not meet accessibility standards Date: 06. September 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – probes
Reference 23117/22

Urgent Field Safety Notice for Syntel Silicone Over the Wire Embolectomy Catheter by LeMaitre Vascular, Inc. PDF, 238KB, File does not meet accessibility standards Date: 06. September 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 22782/22

06. September 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 22432/22

Urgent Field Safety Notice for GORE®Molding and Occlusion Balloon Catheter by W.L. Gore & Associates, Inc. PDF, 51KB, File does not meet accessibility standards Date: 05. September 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 14345/21

Urgent Field Safety Notice for Softe HD Click by Lenstec (Barbados) Inc. PDF, 518KB, File does not meet accessibility standards Date: 02. September 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 22726/22

Urgent Field Safety Notice for CrossSnare by FUJIFILM medwork GmbH PDF, 2MB, File does not meet accessibility standards Date: 01. September 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 19757/22

Urgent Field Safety Notice for N Antiserum to Human IgG by Siemens Healthcare Diagnostics Products GmbH PDF, 376KB, File does not meet accessibility standards Date: 01. September 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 21001/22

Urgent Field Safety Notice for Journey Tibial Spacer Block Standard by Smith & Nephew, Inc., PDF, 72KB, File does not meet accessibility standards Date: 01. September 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 21865/22

Urgent Field Safety Notice for XFINE by MicroPort CRM PDF, 1MB, File does not meet accessibility standards Date: 01. September 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – cardiac pacemakers
Reference 22400/22

Urgent Field Safety Notice for Avance CS2, Avance CS2 Pro, Aisys CS2 by Datex-Ohmeda, Inc. PDF, 555KB, File does not meet accessibility standards Date: 31. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 22100/22

Urgent Field Safety Notice for Bentrio by Laboratoires Chemineau PDF, 170KB, File does not meet accessibility standards Date: 31. August 2022 Topics: Medical devices Type: Customer information

Product group Physical therapy – inhalation therapy
Reference 18526/22

Urgent Field Safety Notice for SOLUS SINGLE USE LARYNGEAL MASK AIRWAY SIZE 3 by Intersurgical Ltd. PDF, 394KB, File does not meet accessibility standards Date: 30. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 22295/22

30. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis procedures
Reference 21278/22

Urgent Field Safety Notice for Carescape Central Station by GE Medical Systems Information Technologies, Inc. PDF, 949KB, File does not meet accessibility standards Date: 29. August 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 09073/22

Urgent Field Safety Notice for Diverse Products with Select Lot Numbers Ending in “R” by Hobbs Medical, Inc. PDF, 2MB, File does not meet accessibility standards Date: 26. August 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 20953/22

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 549KB, File does not meet accessibility standards Date: 26. August 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 04316/21

Urgent Field Safety Notice for GELITA ENT X-PAND / GELITA-SPON RAPID by GELITA MEDICAL GmbH PDF, 968KB, File does not meet accessibility standards Date: 26. August 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – ointments and gels
Reference 20408/22

Urgent Field Safety Notice for Intra-Aortic Balloon Catheters by Datascope Corporation PDF, 742KB, File does not meet accessibility standards Date: 25. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 20313/22

Urgent Field Safety Notice for Cobalt XT, Cobalt and Crome ICDs and CRT-Ds by Medtronic Inc PDF, 863KB, File does not meet accessibility standards Date: 25. August 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – defibrillators
Reference 15321/22

Urgent Field Safety Notice for CorVocet Biopsy System by Merit Medical Systems Inc. PDF, 132KB, File does not meet accessibility standards Date: 23. August 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – gynaecology
Reference 20770/22

Urgent Field Safety Notice for Connector Box of Imaging Module IM 910 by Haag-Streit AG PDF, 159KB, File does not meet accessibility standards Date: 23. August 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 20196/22

Urgent Field Safety Notice for Hamilton-C6 by Hamilton Medical AG PDF, 1,005KB, File does not meet accessibility standards Date: 23. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 21484/22

22. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 20097/22

Urgent Field Safety Notice for Silicone Resuscitator Set; for infant by VBM Medizintechnik GmbH PDF, 324KB, File does not meet accessibility standards Date: 19. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 20858/22

Urgent Field Safety Notice for APL 2002 Infusionspumpenbesteck by pfm medical mepro gmbh PDF, 973KB, File does not meet accessibility standards Date: 19. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 18867/22

Urgent Field Safety Notice for Carescape Central Station by GE Medical Systems Information Technologies, Inc. PDF, 179KB, File does not meet accessibility standards Date: 18. August 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 19599/22

Urgent Field Safety Notice for Secutray by SENGEWALD Klinikprodukte GmbH PDF, 1MB, File does not meet accessibility standards Date: 18. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 14192/22

Urgent Field Safety Notice for Percutaneous dilator set by Coloplast A/S PDF, 106KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 19440/22

Urgent Field Safety Notice for LM150TD by Löwenstein Medical Technology GmbH + Co. KG PDF, 612KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 20875/22

Urgent Field Safety Notice for Dimension Vista CA 15-3 Flex reagent cartride by Siemens Healthcare Diagnostics Inc. Newark PDF, 334KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 18244/22

Urgent Field Safety Notice for Technomed – Disposable Subdermal Needle Electrode by Technomed Europe PDF, 272KB, File does not meet accessibility standards Date: 16. August 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 19863/22

Urgent Field Safety Notice for Obstetric suction cup/Geburtshilfe-Saugnapf by Beijing HangTian KaDi Technology R&D Institute PDF, 659KB, File does not meet accessibility standards Date: 16. August 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – gynaecology
Reference 20470/22

15. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 18079/22

Urgent Field Safety Notice for V-MAX² Pushing and braking aid by AAT Alber Antriebstechnik GmbH PDF, 79KB, File does not meet accessibility standards Date: 15. August 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – mobility aids
Reference 20179/22

Urgent Field Safety Notice for Vollsilikonkatheter Nelaton integral by Haiyan Kangyuan Medical Instrument CO. PDF, 76KB, File does not meet accessibility standards Date: 11. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 17777/22

Urgent Field Safety Notice for Original-Perfusorleitung PE 200 cm by B. Braun Melsungen AG PDF, 537KB, File does not meet accessibility standards Date: 11. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 18746/22

Urgent Field Safety Notice for IP2000K by Tricumed Medizintechnik GmbH PDF, 296KB, File does not meet accessibility standards Date: 10. August 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – drug pumps
Reference 18809/22

Urgent Field Safety Notice for myoncare by ONCARE GmbH PDF, 368KB, File does not meet accessibility standards Date: 10. August 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 19699/22

Urgent Field Safety Notice for BEWATEC.Wandarm 500 plus by Wilfried Krömker Medizintechnik GmbH PDF, 3MB, File does not meet accessibility standards Date: 10. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 19054/22

Urgent Field Safety Notice for Leica Biosystems Tissue processor by Leica Biosystems Nussloch GmbH PDF, 3MB, File does not meet accessibility standards Date: 08. August 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 12657/22

Urgent Field Safety Notice for Infusomat Space by B. Braun Melsungen AG, Sparte Hospital Care PDF, 514KB, File does not meet accessibility standards Date: 03. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 24012/21

Urgent Field Safety Notice for neuroinspire (accessory of the neuromate system) by RENISHAW mayfield PDF, 2MB, File does not meet accessibility standards Date: 03. August 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 16715/22

03. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 19407/22

Urgent Field Safety Notice for NeuRx Diaphragm Pacing System (NeuRx DPS) External by Synapse Biomedical, Inc. PDF, 129KB, File does not meet accessibility standards Date: 02. August 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – biostimulators
Reference 19264/22

Urgent Field Safety Notice for Assurity, Endurity by Abbott Sylmar PDF, 53KB, File does not meet accessibility standards Date: 02. August 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – cardiac pacemakers
Reference 16448/22

Urgent Field Safety Notice for Silaro Exchange Kit by optimed Medizinische Instrumente GmbH PDF, 1MB, File does not meet accessibility standards Date: 01. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 18531/22

Urgent Field Safety Notice for BD Connecta by Becton Dickinson Infusion Therapy AB PDF, 387KB, File does not meet accessibility standards Date: 01. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 10169/22

Urgent Field Safety Notice for Tumark Vision, Tumark Vision for Brevera/Eviva by Somatex Medical Technologies GmbH / Berlin PDF, 422KB, File does not meet accessibility standards Date: 28. July 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – gynaecology
Reference 18263/22

Urgent Field Safety Notice for iCLAS Cryoablation Catheter by Adagio Medical Inc. PDF, 254KB, File does not meet accessibility standards Date: 27. July 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 12699/22

Urgent Field Safety Notice for BrightSpeed (Elite/Edge/Excel/Select), Brivo (CT315/CT325 +CT385), HiSpeed Dual, ProSpeed FII, HiSpeed Series, CTe, ProSpeed AI/FI, CTe Dual, ProSpeed AII/FII, Optima CT520 Series (+ with DoD), Optima Advance, Optima CT540, Optima by GE Hangwei Medical Systems CO., LTD PDF, 171KB, File does not meet accessibility standards Date: 27. July 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 17016/22

Urgent Field Safety Notice for Simplify Artificial Cervical Disc by NuVasive, Inc. PDF, 2MB, File does not meet accessibility standards Date: 27. July 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 15008/22

Urgent Field Safety Notice for ATTUNE Measured Sizing & Rotation Guide Instrumen by DePuy Ireland UC PDF, 833KB, File does not meet accessibility standards Date: 27. July 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 15862/22

27. July 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – medical apps
Reference 17791/22

Urgent Field Safety Notice for EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM by ev3, Inc. PDF, 100KB, File does not meet accessibility standards Date: 27. July 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 17479/22

Urgent Field Safety Notice for Cordis S.M.A.R.T. Flex Vascular Stent System by Cordis Cashel PDF, 628KB, File does not meet accessibility standards Date: 27. July 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 22429/21

Urgent Field Safety Notice for Medicina ENfit reusable enteral syringes and Medic by Medicina Ltd Blackrod PDF, 215KB, File does not meet accessibility standards Date: 27. July 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 17627/22

Urgent Field Safety Notice for NexSys by Haemonetics Corporation PDF, 1MB, File does not meet accessibility standards Date: 27. July 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis procedures
Reference 18347/22

Urgent Field Safety Notice for Microvisc 1%, Microvisc Plus 1,4%, Microvisc Phaco 2,5% by HOYA Surgical Optics GmbH PDF, 152KB, File does not meet accessibility standards Date: 22. July 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – liquid media for ophthalmological purposes
Reference 12647/22

Urgent Field Safety Notice for NEXUS Aortic Arch Stent Graft System by Endospan Ltd. PDF, 425KB, File does not meet accessibility standards Date: 21. July 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 17506/22

Urgent Field Safety Notice for WSI MX/PX-Titan(R) Expertise (Integration) by PETER BREHM GmbH PDF, 340KB, File does not meet accessibility standards Date: 21. July 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 14452/22

Urgent Field Safety Notice for VIDAS FT4 by bioMérieux S. (Marcy- l’Etoile) PDF, 310KB, File does not meet accessibility standards Date: 19. July 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 17322/22

Urgent Field Safety Notice for BD PhaSeal Y-Site Connector C80 by Becton Dickinson & Co. Ltd. PDF, 190KB, File does not meet accessibility standards Date: 19. July 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 17625/22

18. July 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – dialysis technology
Reference 17242/22

Urgent Field Safety Notice for Atellica CH Iron_2 by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 154KB, File does not meet accessibility standards Date: 18. July 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 16850/22

Urgent Field Safety Notice for Codman CereLink ICP Monitor by Integra LifeSciences Corp. PDF, 2MB, File does not meet accessibility standards Date: 18. July 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 15574/22

Urgent Field Safety Notice for Sterile FENESTRA und FORMAR HWS Cages by FEHLING INSTRUMENTS GmbH & Co. KG PDF, 772KB, File does not meet accessibility standards Date: 14. July 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 12667/22

Urgent Field Safety Notice for Pentacam HR, Pentacam AXL, Pentacam AXL Wave by OCULUS Optikgeräte GmbH PDF, 245KB, File does not meet accessibility standards Date: 14. July 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 16925/22

Urgent Field Safety Notice for Venflon Pro Safety by Becton Dickinson Infusion Therapy AB PDF, 325KB, File does not meet accessibility standards Date: 14. July 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Reference 09630/22

Urgent Field Safety Notice for SCENARIA View, Supria, FUJIFILM FCT Speedia by FUJIFILM Corporation PDF, 131KB, File does not meet accessibility standards Date: 13. July 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 16224/22

Urgent Field Safety Notice for Accu-Chek Aviva, Performa and Inform II test strip by Roche Diabetes Care GmbH PDF, 324KB, File does not meet accessibility standards Date: 13. July 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 15139/21

Urgent Field Safety Notice for WEREWOLF FLOW 90 COBLATION WAND by ArthroCare Corporation PDF, 78KB, File does not meet accessibility standards Date: 13. July 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 15405/22

Urgent Field Safety Notice for Medfusion Model 3500; Medfusion Model 4000 by Smiths Medical ASD, lnc. PDF, 518KB, File does not meet accessibility standards Date: 12. July 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 07542/22

12. July 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 16848/22

Urgent Field Safety Notice for CustomEyes by Beaver Visitec International, Ltd PDF, 217KB, File does not meet accessibility standards Date: 12. July 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Reference 15222/22

Urgent Field Safety Notice for Ulti med hCG by ulti med Products (Deutschland) GmbH PDF, 882KB, File does not meet accessibility standards Date: 11. July 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 13170/22

Urgent Field Safety Notice for ZOOM Latitude Programmer by Boston Scientific CRM PDF, 275KB, File does not meet accessibility standards Date: 11. July 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – cardiac pacemakers
Reference 16772/22

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 253KB, File does not meet accessibility standards Date: 11. July 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 15847/22

Urgent Field Safety Notice for INOmax DSIR (Delivery System) by Mallinckrodt Manufacturing LLC PDF, 1MB, File does not meet accessibility standards Date: 11. July 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 14694/22

Urgent Field Safety Notice for ENT-single-use suction tubes by Spiggle & Theis Medizintechnik GmbH PDF, 588KB, File does not meet accessibility standards Date: 11. July 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 16423/22

Urgent Field Safety Notice for EMBLEM S-ICD and EMBLEM MRI S-ICD by Cardiac Pacemaker Inc.- A wholly owned subsidiary of Guidant Corporation – A wholly owned subsidiary PDF, 243KB, File does not meet accessibility standards Date: 11. July 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – defibrillators
Reference 11239/19

Urgent Field Safety Notice for ED-FLOW, ED-FLOW S. by Getinge Disinfection AB PDF, 758KB, File does not meet accessibility standards Date: 11. July 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 16369/22

Urgent Field Safety Notice for YelloPort Elite Universal Seal by Surgical Innovations Limited PDF, 2MB, File does not meet accessibility standards Date: 08. July 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – visceral surgery
Reference 13908/22

07. July 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – ENT equipment
Reference 15281/22

Urgent Field Safety Notice for Task Force CARDIO by CNSystems Medizintechnik GmbH PDF, 2MB, File does not meet accessibility standards Date: 07. July 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 16432/22

Urgent Field Safety Notice for NCB screws by Zimmer Switzerland Manufacturing GmbH PDF, 1MB, File does not meet accessibility standards Date: 06. July 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 14070/22

Urgent Field Safety Notice for NucliSENS easyMAG Magnetic Silica NucliSENS Mag by bioMérieux S. (Marcy- l’Etoile) PDF, 723KB, File does not meet accessibility standards Date: 06. July 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 16201/22

Urgent Field Safety Notice for astraia software for women’s health by astraia software gmbh PDF, 351KB, File does not meet accessibility standards Date: 06. July 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 03225/22

Urgent Field Safety Notice for Centricity PACS by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 238KB, File does not meet accessibility standards Date: 05. July 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 16058/22

Urgent Field Safety Notice for Primedic HeartSave AED by Metrax GmbH PDF, 274KB, File does not meet accessibility standards Date: 04. July 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 05284/22

Urgent Field Safety Notice for Straight Rod; Size Ø4.0×120 mm Ti by K2M Inc. PDF, 593KB, File does not meet accessibility standards Date: 04. July 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 12509/22

Urgent Field Safety Notice for DracoHydro by Dr. Ausbüttel & Co. GmbH PDF, 278KB, File does not meet accessibility standards Date: 04. July 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 15443/22

Urgent Field Safety Notice for Xhibit Telemetry Receiver by Spacelabs Healthcare Snoqualmie PDF, 117KB, File does not meet accessibility standards Date: 04. July 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 15630/22

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