Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2022 – 31.03.2022

Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2022 – 31.03.2022

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 Remel Culti-Loops Candida albicans ATCC 10231 by Thermo Fisher Scientific (Lenexa) PDF, 622KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 06758/22

Urgent Field Safety Notice for Morcellator 5-times-use-Model: moresolution V 2.0 by Trokamed GmbH PDF, 342KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 06645/22

Urgent Field Safety Notice for Biopsieprodukte by ADRIA S.R.L. PDF, 179KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Reference 07212/21

Urgent Field Safety Notice for ALPS; DVR; Juggerloc; SnapShot by Biomet Orthopedics, LLC PDF, 769KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 05377/22

Urgent Field Safety Notice for IN.PACT ADMIRAL Paclitaxel-Eluting PTA Balloon Catheter by Medtronic Ireland PDF, 59KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 06872/22

Urgent Field Safety Notice for PrisMax, V2 ROW PrisMax V3 ROW by Baxter Healthcare S. (Opfikon) PDF, 422KB, File does not meet accessibility standards Date: 29. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – dialysis technology
Reference 06643/22

Urgent Field Safety Notice for Getinge 9100-Series by Getinge Disinfection AB PDF, 839KB, File does not meet accessibility standards Date: 29. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 05952/22

Urgent Field Safety Notice for GOT Multi C2F6 by Al.CHI.MI.A. SRL PDF, 3MB, File does not meet accessibility standards Date: 29. March 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – other medical devices for ophthalmological purposes
Reference 03244/22

Urgent Field Safety Notice for TENEO by Sirona Dental Systems GmbH PDF, 133KB, File does not meet accessibility standards Date: 25. March 2022 Topics: Medical devices Type: Customer information

Product group Dental products – dental treatment units
Reference 06628/22

Urgent Field Safety Notice for Infant/Child SMART Pads Cartridge Adult SMART Pads by Philips Healthcare, Bothell PDF, 629KB, File does not meet accessibility standards Date: 24. March 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 05188/22

Urgent Field Safety Notice for MR systems with Twinspeed by GE Medical Systems, LLC PDF, 110KB, File does not meet accessibility standards Date: 24. March 2022 Topics: Medical devices Type: Customer information

Product group Electromedical fields – equipment for MR tomography
Reference 05635/22

Urgent Field Safety Notice for syngo.via RT Image Suite by Siemens Healthcare GmbH, SYNGO (SY) PDF, 2MB, File does not meet accessibility standards Date: 24. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 05757/22

Urgent Field Safety Notice for Bexen Cardio Paediatric Pads for Defibrillation by FIAB SpA PDF, 216KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 05947/22

Urgent Field Safety Notice for ORAcollect DNA / ORAcollect RNA / ORAcollect Dx by DNA Genotek Inc PDF, 1MB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – auxiliary equipment
Reference 06086/22

Urgent Field Safety Notice for AlboGraft Polyester Vascular Graft by LeMaitre Vascular, Inc. PDF, 946KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 04068/22

Urgent Field Safety Notice for FRED easyport plus by Schiller AG PDF, 314KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 05384/22

Urgent Field Safety Notice for Extremity Pack by Medline International France SAS PDF, 810KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 06074/22

Urgent Field Safety Notice for ProSpecT STEC Shiga Toxin E. coli Microplate Assay by Thermofisher Scientific PDF, 170KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 06321/22

Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland B.V. PDF, 2MB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 03256/22

Urgent Field Safety Notice for IMMULITE 2000 HCG by Siemens Healthcare Diagnostics Products Ltd. PDF, 322KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 04768/22

Urgent Field Safety Notice for Esophageal/Rectal Temperature Probes by Philips Medical Systems PDF, 3MB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 03541/22

Urgent Field Safety Notice for Revolution CT by GE Medical Systems LLC PDF, 248KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 05982/22

Urgent Field Safety Notice for Mycoplasma genitalium Control Panel by Microbiologics, Inc. PDF, 287KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 06204/22

Urgent Field Safety Notice for Atellica UAS 800 analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 264KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 05015/22

Urgent Field Safety Notice for LumiraDx Platform Instrument V5E by LumiraDx UK Ltd PDF, 349KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 05593/22

Urgent Field Safety Notice for Movicol Beutel by Norgine BV PDF, 2MB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Physical therapy – hydrotherapy
Reference 03667/22

Urgent Field Safety Notice for Anti-ß2-Glykoprotein ELISA (IgAGM) by EUROIMMUN Medizinische Labordiagnostika AG PDF, 311KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 05175/22

Urgent Field Safety Notice for Symbia Intevo 6 and Symbia Intevo Bold by Siemens Medical Systems, Inc. PDF, 385KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 06320/22

Urgent Field Safety Notice for COMPELLA SCALE RENTAL by Hill-Rom Company, Inc. PDF, 180KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – furnishings
Reference 04230/22

Urgent Field Safety Notice for V8 by Helena Biosciences Europe PDF, 195KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 29284/21

Urgent Field Safety Notice for Atellica IM/ADVIA Centaur Enhanced Estradiol (eE2) by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 50KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 05735/22

Urgent Field Safety Notice for ARCHITECT S.A. Myoglobin Calibrators by Abbott Laboratories (Abbott Park) PDF, 147KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 05738/22

Urgent Field Safety Notice for NeuMoDx Cartridge by NeuMoDx Molecular, a QIAGEN Company PDF, 103KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 03872/22

Urgent Field Safety Notice for HemosIL AcuStar ADAMTS13-Activity Assay by Instrumentation Laboratory Co. PDF, 203KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 04426/22

Urgent Field Safety Notice for Hy-Care (multi-purpose solution) by CooperVision Manufacturing Limited PDF, 322KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – contact lenses
Reference 03121/22

Urgent Field Safety Notice for 20/30 INDEFLATORTM, INDEFLATORTM Plus 30 and Priority Packs by Abbott Vascular, Santa Clara PDF, 244KB, File does not meet accessibility standards Date: 21. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 05871/22

Urgent Field Safety Notice for AlboGraft Polyester Vascular Graft by LeMaitre Vascular, Inc. PDF, 261KB, File does not meet accessibility standards Date: 21. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 03253A/22

Urgent Field Safety Notice for CoreHipTrial Neck, CoreHip Primary Calcar Cutting Guide by Aesculap AG PDF, 2MB, File does not meet accessibility standards Date: 21. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 05172/22

Urgent Field Safety Notice for Access-9 and AccessPLUS Hemostasis Valves by Merit Medical Systems Inc. PDF, 304KB, File does not meet accessibility standards Date: 21. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 05869/22

Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG PDF, 755KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 04016/22

Urgent Field Safety Notice for SpaceOAR and SpaceOAR Vue Systems by Boston Scientific Corporation Marlborough PDF, 254KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 04592/22

Urgent Field Safety Notice for Sonialvision Series (G4/Safire17/UD150B-40) by Shimadzu Corporation PDF, 102KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 04848/22

Urgent Field Safety Notice for Nextra Hammertoe Correction System by Nextremity Solutions, Inc. PDF, 15MB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 05327/22

Urgent Field Safety Notice for Infinity Central Station CPU by Drägerwerk AG & Co. KGaA PDF, 166KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 05490/22

Urgent Field Safety Notice for NATURA LP57 HCA DURA CVXCTF13-35 1X5EUR by ConvaTec Limited Deeside PDF, 2MB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – care of natural and artificial body orifices
Reference 00418/22

Urgent Field Safety Notice for Vessel Sealer Extend; SynchroSeal by Intuitive Surgical, Inc. PDF, 630KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 05503/22

Urgent Field Safety Notice for Ultima Activator II Reusable Drive Mech by Maquet Cardiovascular PDF, 287KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – cardiac/thorax surgery
Reference 03531/22

Urgent Field Safety Notice for Diagnostic Package Pulse Oxymetry/Capnography by Imtmedical AG PDF, 324KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 31491/21

Urgent Field Safety Notice for Original and Essential Kit Pedicle Screw systems by Safe Orthopaedics PDF, 895KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 03807/22

Urgent Field Safety Notice for SonoFlex EBUS – Nitinol Nadel by Endo-Flex GmbH PDF, 102KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 04411/22

Urgent Field Safety Notice for Philips StentBoost Live used with Philips Allura a by Philips Medical Systems Nederland B.V. PDF, 2MB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 02773/22

Urgent Field Safety Notice for UNIVERSAL TWINBAR 670 by Liko AB PDF, 221KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 04287/22

Urgent Field Safety Notice for Alinity m System by Abbott Molecular, Inc PDF, 457KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 03656/22

Urgent Field Safety Notice for cobas 8000 core unit, cobas pro sample supply unit, cobas c 513 analyzer commercial system by Hitachi High-Technologies Corporation PDF, 279KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 20540/20

Urgent Field Safety Notice for MabTrack level infliximab by Sanquin Reagents PDF, 3MB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 02802/22

Urgent Field Safety Notice for Vasofix Safety, Vasofix Certo by B. Braun Melsungen AG PDF, 241KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Reference 05385/22

Urgent Field Safety Notice for Sentinex Pro/Smart Surgical gown by Lohmann und Rauscher GmbH & Co. KG PDF, 210KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 04568/22

Urgent Field Safety Notice for Jobst Compri2 / Jobst Compri2 Lite by BSN medical GmbH PDF, 271KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – orthoses
Reference 02261/22

Urgent Field Safety Notice for Pharmagel Breast pads, GEL7075 by Pharmaplast S.A.E. PDF, 4MB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – others
Reference 05023/22

Urgent Field Safety Notice for Alinity m System by Abbott Molecular, Inc PDF, 482KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 29538/21

Urgent Field Safety Notice for Trinity Acetabular Hip System by Corin Medical Ltd. PDF, 208KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 04328/22

Urgent Field Safety Notice for cobas z 480 analyzer by Roche Molecular Systems, Inc. PDF, 511KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 20189/20

Urgent Field Safety Notice for V40 BIOLOX delta Ceramic Femoral Head by Stryker Orthopaedics-Mahwah PDF, 998KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 01953/22

Urgent Field Safety Notice for Randox Total Bile Acids by Randox Laboratories Ltd PDF, 3MB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 04972/22

Urgent Field Safety Notice for NextSeq 550Dx by Illumina, Inc. PDF, 829KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 04259/22

Urgent Field Safety Notice for EXALT Model D Single-Use Duodenoscope by Boston Scientific Corporation Marlborough PDF, 126KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 05275/22

Urgent Field Safety Notice for AGILON glenoid components by implantcast GmbH PDF, 1MB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 00432/22

Urgent Field Safety Notice for ExacTrac Dynamic by Brainlab AG PDF, 273KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 04414/22

Urgent Field Safety Notice for Lithium_2 (LITH_2) reagents Enzymatic Hemoglobin A1c (A1c_E) reagents by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 669KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 03252/22

Urgent Field Safety Notice for Tubing Sets for Hemodialysis / DORA by Bain Medical Equipment (Guangzhou) Co. Ltd. PDF, 131KB, File does not meet accessibility standards Date: 11. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – dialysis technology
Reference 05874/22

Urgent Field Safety Notice for Artis zee/Q/Q.zen systems by Siemens Healthcare GmbH Advanced Therapies PDF, 658KB, File does not meet accessibility standards Date: 10. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 04080/22

Urgent Field Safety Notice for VERTICALE S. Schraubendreher Hülse by Silony Medical GmbH PDF, 148KB, File does not meet accessibility standards Date: 08. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 03583/22

Urgent Field Safety Notice for Dismozon plus by BODE Chemie GmbH PDF, 308KB, File does not meet accessibility standards Date: 08. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 03553/22

Urgent Field Safety Notice for LiquiBand FIX8 by Advanced Medical Solutions (Plymouth) Ltd PDF, 2MB, File does not meet accessibility standards Date: 08. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 03243/22

Urgent Field Safety Notice for Soft suction liner by Medline Industries, Inc PDF, 677KB, File does not meet accessibility standards Date: 08. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 29290/21

Urgent Field Safety Notice for JOURNEY UNI CoCr Femoral: by Smith & Nephew, Inc., PDF, 120KB, File does not meet accessibility standards Date: 08. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 03232/22

Urgent Field Safety Notice for EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180V by Olympus Medical Systems Corp. PDF, 151KB, File does not meet accessibility standards Date: 08. March 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 26319/21

Urgent Field Safety Notice for t:slim X2 Insulin Pump by Tandem Diabetes Care, Inc PDF, 185KB, File does not meet accessibility standards Date: 08. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 03145/22

Urgent Field Safety Notice for NEFA Unveresterte Fettsäuren by Labor+Technik Eberhard Lehmann GmbH PDF, 2MB, File does not meet accessibility standards Date: 04. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 01997/22

Urgent Field Safety Notice for VIDAS High Sensitive Troponin I by bioMérieux S. (Marcy- l’Etoile) PDF, 382KB, File does not meet accessibility standards Date: 04. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 02006/22

Urgent Field Safety Notice for recomScan Software (BLOTrix System) by Mikrogen GmbH PDF, 50KB, File does not meet accessibility standards Date: 04. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 02048/22

Urgent Field Safety Notice for Aqua Sense III-130 PAL by Aaren Scientific Inc. PDF, 9MB, File does not meet accessibility standards Date: 28. February 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 02911/22

Urgent Field Safety Notice for Lagerungsrolle, -hilfe by Fuhrmann GmbH PDF, 667KB, File does not meet accessibility standards Date: 24. February 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – pads and diapers
Reference 02014/22

Urgent Field Safety Notice for Laerdal Suction Unit (LSU) by Laerdal Medical AS (LMAS) PDF, 221KB, File does not meet accessibility standards Date: 24. February 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 31240/21

Urgent Field Safety Notice for Level 1 Fast Flow Fluid Warming System and Level 1® NORMOFLO Irrigation System by Smiths Medical ASD, Inc. (Plymouth) PDF, 311KB, File does not meet accessibility standards Date: 24. February 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Reference 17485/21

Urgent Field Safety Notice for synedra AIM by Synedra Information Technologies GmbH PDF, 193KB, File does not meet accessibility standards Date: 24. February 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 03533/22

Urgent Field Safety Notice for Elisa Trolley by Löwenstein Medical GmbH & Co. KG PDF, 131KB, File does not meet accessibility standards Date: 24. February 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 03377/22

Urgent Field Safety Notice for Artis icono and Artis pheno by Siemens Healthcare GmbH Advanced Therapies PDF, 2MB, File does not meet accessibility standards Date: 24. February 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 03276/22

Urgent Field Safety Notice for Cliny Port System by Create Medic Co., LTD. PDF, 301KB, File does not meet accessibility standards Date: 24. February 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 03149/22

Urgent Field Safety Notice for Alinity s System by Abbott GmbH PDF, 238KB, File does not meet accessibility standards Date: 24. February 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 02901/22

Urgent Field Safety Notice for oneHbA1c IS by DiaSys Diagnostic Systems GmbH PDF, 426KB, File does not meet accessibility standards Date: 24. February 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 02693/22

Urgent Field Safety Notice for Arrow: Catheter Introduction Needle, Central Venous Catheter, General Purpose syringe, Haemostasis valve obturator, Instrument guard, single-use, Vascular catheter introduction kit, Vascular catheterization support kit by Arrow International Inc. PDF, 267KB, File does not meet accessibility standards Date: 22. February 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 09812/21

Urgent Field Safety Notice for ED-FLOW, ED-FLOW S. by Getinge Disinfection AB PDF, 816KB, File does not meet accessibility standards Date: 22. February 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 02220/22

Urgent Field Safety Notice for Infusomat Space Line Type Transfusion by B. Braun Melsungen AG PDF, 128KB, File does not meet accessibility standards Date: 21. February 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 02946/22

Urgent Field Safety Notice for PiCCO Monitoring Kit + ProAQT Sensor by PULSION Medical Systems SE PDF, 263KB, File does not meet accessibility standards Date: 21. February 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 02402/22

Urgent Field Safety Notice for OF-03-01-0038 by Leica Microsystems (Schweiz) AG PDF, 104KB, File does not meet accessibility standards Date: 21. February 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
Reference 02058/22

Urgent Field Safety Notice for Ohrklappen, unsteril, weiß by Fuhrmann Verbandstoffe GmbH PDF, 688KB, File does not meet accessibility standards Date: 21. February 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 02657/22

Urgent Field Safety Notice for PediatrOS RigidTack by Merete Medical GmbH PDF, 260KB, File does not meet accessibility standards Date: 21. February 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 02011/22

Urgent Field Safety Notice for Ysio by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 517KB, File does not meet accessibility standards Date: 18. February 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 02133/22

Urgent Field Safety Notice for several GE Healthcare MRI systems with superconducting magnets by GE Medical Systems, LLC PDF, 161KB, File does not meet accessibility standards Date: 18. February 2022 Topics: Medical devices Type: Customer information

Product group Electromedical fields – equipment for MR tomography
Reference 02658/22

Urgent Field Safety Notice for Evita V300; Evita V500; Babylog VN500 by Drägerwerk AG & Co. KGaA PDF, 49KB, File does not meet accessibility standards Date: 18. February 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 02710/22

Urgent Field Safety Notice for Minisart by Sartorius Stedim Biotech GmbH PDF, 69KB, File does not meet accessibility standards Date: 18. February 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – filters
Reference 02377/22

Urgent Field Safety Notice for Ventilator Trolley by Breas Medical AB PDF, 180KB, File does not meet accessibility standards Date: 18. February 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 02375/22

Urgent Field Safety Notice for RESOLVE HALO by Össur hf. PDF, 256KB, File does not meet accessibility standards Date: 14. February 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 02247/22

Urgent Field Safety Notice for Mechanisches/Pneumatisches Knie Genex by ORTHO-REHA Neuhof GmbH PDF, 203KB, File does not meet accessibility standards Date: 12. February 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – prostheses (exoprostheses)
Reference 01158/22

Urgent Field Safety Notice for DD Prefab DFX 38 / 45 / 55 Set by Dental Direkt GmbH PDF, 147KB, File does not meet accessibility standards Date: 12. February 2022 Topics: Medical devices Type: Customer information

Product group Dental products – dental implants
Reference 02124/22

Urgent Field Safety Notice for Dopplex by Huntleigh Healthcare Ltd. Diagnostics PDF, 2MB, File does not meet accessibility standards Date: 12. February 2022 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 02514/22

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB PDF, 1MB, File does not meet accessibility standards Date: 11. February 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 00108/22

Urgent Field Safety Notice for Glace Custom Made CMF Implant by Skulle Implants Corporation PDF, 138KB, File does not meet accessibility standards Date: 11. February 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 02121/22

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 95KB, File does not meet accessibility standards Date: 11. February 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 02363/22

Urgent Field Safety Notice for BIP O-Twist-Marker SRX by BIP Biomedizinische Instrumente & Produkte GmbH PDF, 7MB, File does not meet accessibility standards Date: 11. February 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 02122/22

Urgent Field Safety Notice for Combihesive and Natura by ConvaTec Limited Deeside PDF, 3MB, File does not meet accessibility standards Date: 11. February 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – care of natural and artificial body orifices
Reference 02223/22

Urgent Field Safety Notice for MEDPOR Titan OFW – MTB – 1.0mm by Stryker Leibinger GmbH & Co. KG PDF, 372KB, File does not meet accessibility standards Date: 08. February 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 31083/21

Urgent Field Safety Notice for Oracol+ Saliva Collection Device by Malvern Medical Developments Ltd PDF, 141KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 02002/22

Urgent Field Safety Notice for QMS Tacrolimus Immunoassay Calibrator kit by Microgenics Corporation PDF, 332KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 00827/22

Urgent Field Safety Notice for SARS-CoV-2 Rapid Antigen Test by S. BIOSENSOR, INC. PDF, 245KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 01731/22

Urgent Field Safety Notice for SARS-CoV-2 Antigen Test Kit (Colloidal Gold) by Genrui Biotech Inc. PDF, 98KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 00496/22

Urgent Field Safety Notice for DERIVO 2 Embolisation Device by Acandis GmbH & Co. KG PDF, 3MB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 01491/22

Urgent Field Safety Notice for BenchMark Ultra by Ventana Medical Systems, Inc PDF, 494KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 00874/22

Urgent Field Safety Notice for SPHERIC RL Bipolar cup by EVOLUTIS SAS PDF, 119KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 28660/21

Urgent Field Safety Notice for CLAW II ORTHOLOC 3DSi Plate/DARCO Screw, Locking by Wright Medical Technology PDF, 856KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 01914/22

Urgent Field Safety Notice for ACUSON Juniper Diagnostic Ultrasound System by Siemens Medical Solutions USA, Inc., Ultrasound Division PDF, 373KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 01588/22

Urgent Field Safety Notice for Everest XT MI Inner Dilator and Outer Dilator by Stryker Spine – K2M – Leesburg PDF, 634KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 01710/22

Urgent Field Safety Notice for Charder Lift Scale by Charder Electronic Co., Ltd. PDF, 286KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 01173/22

Urgent Field Safety Notice for Insulinpumpe der MiniMed 600- und 700-Serie by Medtronic Minimed PDF, 185KB, File does not meet accessibility standards Date: 04. February 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 02004/22

Urgent Field Safety Notice for C-Peptide ELISA by DRG Instruments GmbH PDF, 3MB, File does not meet accessibility standards Date: 31. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 31794/21

Urgent Field Safety Notice for EUROLabWorkstation ELISA by EUROIMMUN Medizinische Labordiagnostika AG PDF, 129KB, File does not meet accessibility standards Date: 31. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 24542/21

Urgent Field Safety Notice for NavitrackER Markers by Zimmer CAS PDF, 754KB, File does not meet accessibility standards Date: 31. January 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 00817/22

Urgent Field Safety Notice for Analytical column, MassChrom Free Metanephrines by Chromsystems Instruments & Chemicals GmbH PDF, 126KB, File does not meet accessibility standards Date: 31. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 01204/22

Urgent Field Safety Notice for DERIVO 2heal Embolisation Device by Acandis GmbH & Co. KG PDF, 3MB, File does not meet accessibility standards Date: 31. January 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 01492/22

Urgent Field Safety Notice for HydroSoft-3D-AV by MicroVention, Inc PDF, 290KB, File does not meet accessibility standards Date: 26. January 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 00941/22

Urgent Field Safety Notice for OPTIMA COIL SYSTEM by BALT USA LLC PDF, 376KB, File does not meet accessibility standards Date: 26. January 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 00490/22

Urgent Field Safety Notice for Celex and Intelli-C EU by NRT-Nordisk Røntgen Teknik A/S PDF, 75KB, File does not meet accessibility standards Date: 26. January 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 00812/22

Urgent Field Safety Notice for Technomed – Disposable Subdermal Needle Electrode, Pt/Ir by Technomed Europe PDF, 1MB, File does not meet accessibility standards Date: 26. January 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 28296/21

Urgent Field Safety Notice for Cefiderocol on Sensititre plates by Thermo Fisher Scientific Microbiology Basingstoke PDF, 141KB, File does not meet accessibility standards Date: 26. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 00517/22

Urgent Field Safety Notice for Ethanolamin IgG/IgM ELISA by IBL International GmbH PDF, 120KB, File does not meet accessibility standards Date: 24. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 01053/22

Urgent Field Safety Notice for Monomax, MonoPlus, Monosyn, Novosyn, PremiCron, PremiPatch and Safil by B. Braun Surgical S.A. PDF, 1MB, File does not meet accessibility standards Date: 24. January 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – surgical sutures, vascular loops etc.
Reference 30436/21

Urgent Field Safety Notice for i.s.h.med by Cerner Corporation PDF, 868KB, File does not meet accessibility standards Date: 24. January 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 16501/21

Urgent Field Safety Notice for GOT (AST) mod. IFCC; GPT (ALT) mod. IFCC by DIALAB GmbH PDF, 3MB, File does not meet accessibility standards Date: 24. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 00832/22

Urgent Field Safety Notice for MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP by Baxter Healthcare SA PDF, 168KB, File does not meet accessibility standards Date: 24. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – dialysis technology
Reference 01052/22

Urgent Field Safety Notice for Perfusor Space by B. Braun Melsungen AG PDF, 184KB, File does not meet accessibility standards Date: 24. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 00590/22

Urgent Field Safety Notice for Quantum Blue Anti-Infliximab by Bühlmann Laboratories AG PDF, 72KB, File does not meet accessibility standards Date: 24. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 00697/22

Urgent Field Safety Notice for LF900/DS MAREF by DAESUNG MAREF CO.,LTD. PDF, 118KB, File does not meet accessibility standards Date: 24. January 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 26906/21

Urgent Field Safety Notice for Natus NeuroWorks/SleepWorks by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) PDF, 243KB, File does not meet accessibility standards Date: 24. January 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 27901/21

Urgent Field Safety Notice for BD SmartSiteNeedle Free Valve by BD Switzerland Sarl PDF, 207KB, File does not meet accessibility standards Date: 21. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 15601/21

Urgent Field Safety Notice for Crespine Gelr + by BioPolymer GmbH & Co. KG – Dümmer PDF, 274KB, File does not meet accessibility standards Date: 20. January 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – materials for implants
Reference 24371/21

Urgent Field Safety Notice for C7211, 5mmX45cm, Epix REUSABLE PROBE by Applied Medical Resources Corporation PDF, 204KB, File does not meet accessibility standards Date: 20. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
Reference 00603/22

Urgent Field Safety Notice for Multi Stage Esophageal Dilation Balloon by Endo-Flex GmbH PDF, 575KB, File does not meet accessibility standards Date: 19. January 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 00578/22

Urgent Field Safety Notice for Prevail Paclitaxel-coated PTCA Balloon Catheter by Medtronic Inc. PDF, 49KB, File does not meet accessibility standards Date: 19. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 00582/22

Urgent Field Safety Notice for Bellavista by Imtmedical AG PDF, 360KB, File does not meet accessibility standards Date: 19. January 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 30904/21

Urgent Field Safety Notice for Conductivity sensor spare part for Dialog machines by B. Braun Avitum AG PDF, 502KB, File does not meet accessibility standards Date: 19. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – dialysis technology
Reference 00489/22

Urgent Field Safety Notice for Guidestar Steerable Guiding Sheath by Oscor Inc. PDF, 910KB, File does not meet accessibility standards Date: 17. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 00521/22

Urgent Field Safety Notice for Liko M220, Liko M230 by Liko AB PDF, 349KB, File does not meet accessibility standards Date: 17. January 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 30622/21

Urgent Field Safety Notice for Inogen Sauerstoffkonzentratoren by Inogen, Inc. PDF, 965KB, File does not meet accessibility standards Date: 17. January 2022 Topics: Medical devices Type: Customer information

Product group Physical therapy – equipment for oxygen therapy
Reference 31226/21

Urgent Field Safety Notice for Traverse Rail Carrier by Liko AB PDF, 216KB, File does not meet accessibility standards Date: 17. January 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – ward equipment and equipment for emergency medical services
Reference 00398/22

Urgent Field Safety Notice for Qstress/Xscribe, Hscribe/Vision Exp, DCS, ConnexCa by Welch Allyn Inc. PDF, 305KB, File does not meet accessibility standards Date: 17. January 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 00462/22

Urgent Field Safety Notice for OP-Sets mit OP-Mänteln by Biocon Medizintechnik GmbH PDF, 179KB, File does not meet accessibility standards Date: 14. January 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 00240/22

Urgent Field Safety Notice for MIC Gastrostomy Tube Care Kit 16 by Avanos Medical Inc PDF, 2MB, File does not meet accessibility standards Date: 14. January 2022 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – others
Reference 00185/22

Urgent Field Safety Notice for INSTRU Plus by Dr.Schumacher Gmbh PDF, 899KB, File does not meet accessibility standards Date: 14. January 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 27923/21

Urgent Field Safety Notice for MultiDiagnost Eleva IITV & MultiDiagnost Eleva FD by Philips Medical Systems Nederland B.V PDF, 4MB, File does not meet accessibility standards Date: 13. January 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 00319/22

Urgent Field Safety Notice for EFTIAR Octane, vials and syringes, 5 ml and 7 ml by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. PDF, 74KB, File does not meet accessibility standards Date: 13. January 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – liquid media for ophthalmological purposes
Reference 30652/21

Urgent Field Safety Notice for Percept by Medtronic Inc PDF, 386KB, File does not meet accessibility standards Date: 13. January 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – biostimulators
Reference 22865/21

Urgent Field Safety Notice for OntoDrug AMTS by Vidal MMI Germany GmbH PDF, 94KB, File does not meet accessibility standards Date: 12. January 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 00311/22

Urgent Field Safety Notice for Rusch TracFlex Plus, Paediatric Tracheostomy Tube Set; RuschCare TracFlex Plus, Paediatric Tracheostomy Tube Set by Teleflex (Perak West Malaysia) PDF, 293KB, File does not meet accessibility standards Date: 12. January 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 30102/21

Urgent Field Safety Notice for MMI-AMTS-Service by Vidal MMI Germany GmbH PDF, 95KB, File does not meet accessibility standards Date: 12. January 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 00310/22

Urgent Field Safety Notice for Solero Microwave Tissue Ablation System Generator by AngioDynamics, Inc. US PDF, 225KB, File does not meet accessibility standards Date: 12. January 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 15229/21

Urgent Field Safety Notice for Simpleware ScanIP Medical by Synopsys Northern Europe Ltd PDF, 191KB, File does not meet accessibility standards Date: 12. January 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 14594/21

Urgent Field Safety Notice for PRECICE System by NuVasive Specialized Orthopedics, Inc., a division of NuVasive, Inc. PDF, 584KB, File does not meet accessibility standards Date: 12. January 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – others
Reference 01857/21

Urgent Field Safety Notice for MMI-AMTS-Service by Vidal MMI Germany GmbH PDF, 96KB, File does not meet accessibility standards Date: 12. January 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 30892/21

Urgent Field Safety Notice for Da Vinci Xi and X Conductive Reducer Tip by Intuitive Surgical, Inc. PDF, 729KB, File does not meet accessibility standards Date: 11. January 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – visceral surgery
Reference 00022/22

Urgent Field Safety Notice for OntoDrug AMTS by Vidal MMI Germany GmbH PDF, 96KB, File does not meet accessibility standards Date: 11. January 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 30701/21

Urgent Field Safety Notice for TaqPath COVID-19 CE-IVD RT-PCR Kit by Life Technologies Corporation, a part of Thermo Fisher Scientific PDF, 193KB, File does not meet accessibility standards Date: 11. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 25208/21

Urgent Field Safety Notice for ID NOW COVID-19 by Abbott Diagnostics Scarborough, Inc. PDF, 99KB, File does not meet accessibility standards Date: 11. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 24580/21

Urgent Field Safety Notice for Evidence Investigator EV3600 by Randox Laboratories Ltd PDF, 3MB, File does not meet accessibility standards Date: 10. January 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 25550/21

Urgent Field Safety Notice for ampliCube HEV 2.0 by Mikrogen GmbH PDF, 105KB, File does not meet accessibility standards Date: 10. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 31037/21

Urgent Field Safety Notice for Aeson Total Artificial Heart by CARMAT SA PDF, 101KB, File does not meet accessibility standards Date: 06. January 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 30905/21

Urgent Field Safety Notice for SynCardia TAH-t System by SynCardia Systems, Inc. PDF, 178KB, File does not meet accessibility standards Date: 06. January 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 31402/21

Urgent Field Safety Notice for Universal Chuck by Synthes GmbH PDF, 270KB, File does not meet accessibility standards Date: 05. January 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 31205/21

Urgent Field Safety Notice for SOPHIE by Fritz Stephan GmbH PDF, 220KB, File does not meet accessibility standards Date: 05. January 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 29533/21

Urgent Field Safety Notice for COOL LINE, ICY, Quattro and Solex IVTM Catheters by ZOLL USA PDF, 135KB, File does not meet accessibility standards Date: 04. January 2022 Topics: Medical devices Type: Customer information

Product group Physical therapy – climatotherapy
Reference 20048/21

Urgent Field Safety Notice for Miami J Cervical Collar by Össur hf PDF, 190KB, File does not meet accessibility standards Date: 04. January 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – orthoses
Reference 23990/21

Urgent Field Safety Notice for UNI SCORE tibial tray for fixed bearing insert by Amplitude S.A.S. PDF, 722KB, File does not meet accessibility standards Date: 04. January 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 30036/21

Urgent Field Safety Notice for CHEMO-SURE by WELFORD MANUFACTURING SDN. BHD. PDF, 231KB, File does not meet accessibility standards Date: 04. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 30183/21

Urgent Field Safety Notice for Push brace by R82 A/S PDF, 2MB, File does not meet accessibility standards Date: 04. January 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – mobility aids
Reference 30410/21

Urgent Field Safety Notice for ID 32 C by bioMérieux S. (Marcy- l’Etoile) PDF, 762KB, File does not meet accessibility standards Date: 04. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – microbiological products
Reference 31404/21

Urgent Field Safety Notice for PATHFILE; PROGLIDER; PROTAPER GOLD by Maillefer Instruments Holding SARL PDF, 161KB, File does not meet accessibility standards Date: 04. January 2022 Topics: Medical devices Type: Customer information

Product group Dental products – instruments
Reference 30434/21

Urgent Field Safety Notice for Trinias, BRANSIST safire,BRANSIST alexa by Shimadzu Corporation PDF, 115KB, File does not meet accessibility standards Date: 04. January 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – mobile radiological diagnostic facilities
Reference 29142/21

Urgent Field Safety Notice for Allura Xper Systems, CV20 Systems and UNIQ systems by Philips Medical Systems Nederland B.V. PDF, 2MB, File does not meet accessibility standards Date: 04. January 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 30794/21

Urgent Field Safety Notice for Centric by HS Doms GmbH PDF, 60KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 30749/21

Urgent Field Safety Notice for Telecentric by HS Doms GmbH PDF, 60KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 31044/21

Urgent Field Safety Notice for Ecocentric by HS Doms GmbH PDF, 60KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 30751/21

Urgent Field Safety Notice for CLiP Ported by Vigmed AB PDF, 267KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 28839/21

Urgent Field Safety Notice for HT Command 18 S. Guide Wire by Abbott Vascular, Santa Clara PDF, 103KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 30766/21

Urgent Field Safety Notice for Olympus TJF-Q170V &TJF-Q190V & TJF-Q290 & MAJ-2315 by Olympus Medical Systems Corp. PDF, 279KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 30197/21

Urgent Field Safety Notice for 3M Coban Self-Adherent Wrap, Latex cont., sterile by 3M Company PDF, 494KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – orthoses
Reference 31033/21

Urgent Field Safety Notice for Lens Care Solution Bottles by CooperVision Manufacturing Limited PDF, 89KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – contact lenses
Reference 31036/21

Urgent Field Safety Notice for Concentric by HS Doms GmbH PDF, 60KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 30750/21

Urgent Field Safety Notice for HS-810 by HS Doms GmbH PDF, 60KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 30752/21

Urgent Field Safety Notice for HS-1410 by HS Doms GmbH PDF, 60KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 30753/21

Urgent Field Safety Notice for a-Globin StripAssay by ViennaLab Diagnostics GmbH PDF, 124KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 29273/21

Urgent Field Safety Notice for ASX Anti-Dekubitus-Wechseldrucksystem by Novacare GmbH PDF, 102KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – furnishings
Reference 30887/21

Urgent Field Safety Notice for Sinus by HS Doms GmbH PDF, 61KB, File does not meet accessibility standards Date: 03. January 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics
Reference 30748/21