Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2023 – 30.09.2023

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 Reverse Shoulder Prosthesis (RSP) Humeral Socket by Encore Medical, LP (dba DJO Surgical) PDF, 1MB, File does not meet accessibility standards 29. September 2023 Medical devices

Customer information

Product group Non-active implants – bone surgery Reference 22772/23

Urgent Field Safety Notice for ENNOVATE by Aesculap AG PDF, 3MB, File does not meet accessibility standards 29. September 2023 Medical devices Customer information

Product group Non-active implants – bone surgery Reference 29079/23

Urgent Field Safety Notice for Humeral reverse metaphysis +0mm/0° by Medacta International SA PDF, 481KB, File does not meet accessibility standards 29. September 2023 Medical device sCustomer information

Product group Non-active implants – bone surgery Reference 24635/23

Urgent Field Safety Notice for Senhance Surgical System by Asensus Surgical Italia S.r.l. PDF, 1MB, File does not meet accessibility standards 28. September 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 28306/23

Urgent Field Safety Notice for UniCel DxI 800/600 and Access 2 Immunoassay Analyzer by Beckman Coulter, Inc. PDF, 1MB, File does not meet accessibility standards 28. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 26123/23

Urgent Field Safety Notice for Randox G6PDH by Randox Laboratories Ltd PDF, 2MB, File does not meet accessibility standards 28. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 29090/23

Urgent Field Safety Notice for Multichem IA Plus controls, Multichem S Plus controls by Techno-path Manufacturing Ltd. PDF, 2MB, File does not meet accessibility standards 28. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 26312/23

Urgent Field Safety Notice for Acrobat-i Stabilizer by Maquet Cardiovascular PDF, 206KB, File does not meet accessibility standards 27. September 2023 Medical devices Customer information

Product group Medical instruments for use in humans – cardiac/thorax surgery Reference 28444/23

Urgent Field Safety Notice for s.a. safe Disinfection Cap by Fresenius Medical Care AG & Co. KGaA PDF, 140KB, File does not meet accessibility standards 27. September 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters Reference 29245/23

Urgent Field Safety Notice for DOSE: Patient radiation dose monitoring software by QAELUM NV PDF, 896KB, File does not meet accessibility standards 26. September 2023 Medical devices Customer information

Product group Medical data processing (software) – others Reference 23027/23

Urgent Field Safety Notice for NEXUS / PDMS by NEXUS / DIS GmbH PDF, 784KB, File does not meet accessibility standards 25. September 2023 Medical devices Customer information

Product group Medical data processing (software) – others Reference 27789/23

Urgent Field Safety Notice for Terumo-Platelet Additive Solution + (T-PAS+) by Terumo BCT Europe N.V. PDF, 441KB, File does not meet accessibility standards 25. September 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells Reference 26678/23

Urgent Field Safety Notice for RelayPro Thoracic Stent Graft System by Bolton Medical lnc. PDF, 613KB, File does not meet accessibility standards 22. September 2023 Medical devices Customer information

Product group Non-active implants – special implants Reference 33177/22

Urgent Field Safety Notice for RayCare 5B SP1, 5B SP3, 6A by RaySearch Laboratories AB PDF, 2MB, File does not meet accessibility standards 22. September 2023 Medical devices Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 28423/23

Urgent Field Safety Notice for OP-Tischzubehör by TRUMPF Medizin Systeme GmbH + Co. KG PDF, 331KB, File does not meet accessibility standards 21. September 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 28529/23

Urgent Field Safety Notice for Conventional Crescent Knife 2.5mm, 55 degrees by Beaver Visitec International, Inc. PDF, 424KB, File does not meet accessibility standards 21. September 2023 Medical devicesCustomer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics Reference 27637/23

Urgent Field Safety Notice for 4500MD and Citrine LC-MS/MS Systems by AB SCIEX Pte. Ltd. PDF, 898KB, File does not meet accessibility standards 21. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 23720/23

Urgent Field Safety Notice for Codman CereLink ICP Monitor by Integra LifeSciences Corp. PDF, 353KB, File does not meet accessibility standards 21. September 2023 Medical devices Customer information

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

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, 128KB, File does not meet accessibility standards 20. September 2023 Medical devices Customer information

Product group Active implantable medical devices – defibrillators Reference 27807/23

Urgent Field Safety Notice for Centricity Enterprise Archive; Enterprise Archive by GE Healthcare PDF, 215KB, File does not meet accessibility standards 18. September 2023 Medical devices Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 27272/23

Urgent Field Safety Notice for VITROS Analyser System by Ortho-Clinical Diagnostics Inc, PDF, 399KB, File does not meet accessibility standards 18. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 24648/23

Urgent Field Safety Notice for HeartSine Samaritan PAD by Heartsine Technologies Limited PDF, 2MB, File does not meet accessibility standards 14. September 2023 Medical devices Customer information

Product group Medical electronics / Electromedical devices – electrotherapy Reference 14335/23

Urgent Field Safety Notice for AIA-CL 300 Immunoassay Analyzer by Tosoh Corporation PDF, 253KB, File does not meet accessibility standards 14. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 24298/23

Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter Inc. PDF, 2MB, File does not meet accessibility standards 14. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 27595/23

Urgent Field Safety Notice for Cios Spin by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 2MB, File does not meet accessibility standards 13. September 2023 Medical devices Customer information

Product group Radiological technology – mobile radiological diagnostic facilities Reference 27238/23

Urgent Field Safety Notice for HYBRID by BALT Extrusion PDF, 1MB, File does not meet accessibility standards 13. September 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters Reference 26735/23

Urgent Field Safety Notice for TruCal Apo A1/B by DiaSys Diagnostic Systems GmbH PDF, 763KB, File does not meet accessibility standards 13. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 26723/23

Urgent Field Safety Notice for ACL TOP Family 50 Series and ACL TOP 970 CL by Instrumentation Laboratory Company PDF, 824KB, File does not meet accessibility standards 13. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products Reference 24734/23

Urgent Field Safety Notice for Biopsy valve Suitable for Fujifilm endoscopes series 500/600 by Yangzhou Fartley Medical Instrument Technology Co., Ltd. PDF, 166KB, File does not meet accessibility standards 13. September 2023 Medical devices Customer information

Product group Optics / Precision engineering – endoscopes Reference 24747/23

Urgent Field Safety Notice for Philips IntelliVue Information Center iX by Philips Medizin Systeme Boblingen GmbH PDF, 1MB, File does not meet accessibility standards 13. September 2023 Medical devices Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics Reference 25503/23

Urgent Field Safety Notice for CardioLab, ComboLab by GE Medical Systems Information Technologies, Inc. PDF, 169KB, File does not meet accessibility standards 11. September 2023 Medical devices Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics Reference 26537/23

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 466KB, File does not meet accessibility standards 11. September 2023 Medical devices Customer information

Product group Medical data processing (software) – others Reference 26492/23

Urgent Field Safety Notice for Mentype DIPquant HLD 84-D CE IVD by Biotype Diagnostic GmbH PDF, 104KB, File does not meet accessibility standards 11. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – immunological products Reference 26928/23

Urgent Field Safety Notice for Fujifilm FDR Visionary Suite by Shimadzu Corporation PDF, 125KB, File does not meet accessibility standards 11. September 2023 Medical devices Customer information

Product group Radiological technology – stationary radiological equipment Reference 26896/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 3MB, File does not meet accessibility standards 08. September 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 23220/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 3MB, File does not meet accessibility standards 08. September 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 23370/23

Urgent Field Safety Notice for Knochenprofilfräser by ALTATEC GmbH PDF, 111KB, File does not meet accessibility standards 08. September 2023 Medical devices Customer information

Product group Dental products – dental implants Reference 23551/23

Urgent Field Safety Notice for Descosept Spezial by Dr. Schumacher GmbH PDF, 115KB, File does not meet accessibility standards 06. September 2023 Medical devices Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation Reference 23946/23

Urgent Field Safety Notice for RSP Glenoid Baseplate HA coating by Encore Medical, LP (dba DJO Surgical) PDF, 1MB, File does not meet accessibility standards 06. September 2023 Medical devices Customer information

Product group Non-active implants – bone surgery Reference 22489/23

Urgent Field Safety Notice for JELCO IV Catheter by Smiths Medical ASD, lnc. PDF, 261KB, File does not meet accessibility standards 06. September 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters Reference 26651/23

Urgent Field Safety Notice for Sprinter Cart, Sprinter Cart XL by Maquet Cardiopulmonary GmbH PDF, 2MB, File does not meet accessibility standards 06. September 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 25672/23

Urgent Field Safety Notice for FARGO / CRISTAL BALLOON by BALT Extrusion PDF, 1MB, File does not meet accessibility standards 06. September 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters Reference 26729/23

Urgent Field Safety Notice for Atellica IM FBHCG; Advia Centaur FBHCG by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 145KB, File does not meet accessibility standards 06. September 2023 Medical devices Customer information

Product group In-vitro diagnostics – immunological products Reference 26662/23

Urgent Field Safety Notice for Spaceplus Infusomat by B. Braun Melsungen AG PDF, 1MB, File does not meet accessibility standards 06. September 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology Reference 24297/23

Urgent Field Safety Notice for Nexus KIS Medikationsmodul by NEXUS / DIS GmbH PDF, 54KB, File does not meet accessibility standards 06. September 2023 Medical devices Customer information

Product group Medical data processing (software) – others Reference 19111/23

Urgent Field Safety Notice for Laguna Duschstuhl/Duschhocker by RUSSKA – Ludwig Bertram GmbH PDF, 340KB, File does not meet accessibility standards 01. September 2023 Medical devices Customer information

Product group Orthopaedic / Rehabilitation technology – daily living aids Reference 20536/23

Urgent Field Safety Notice for IndiGo Intuitive Drive Assistance by ArjoHuntleigh AB Malmö PDF, 259KB, File does not meet accessibility standards 01. September 2023 Medical devices Customer information

Product group General equipment for medical treatment – furnishings Reference 25373/23

Urgent Field Safety Notice for Los Deline by BIOTRH s.r.o. PDF, 158KB, File does not meet accessibility standards 01. September 2023 Medical devices Customer information

Product group Non-active implants – materials for implants Reference 22492/23

Urgent Field Safety Notice for In2Flow Nasal cannula by Hamilton Medical AG PDF, 230KB, File does not meet accessibility standards 01. September 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply Reference 26046/23

Urgent Field Safety Notice for Gallant, Neutrino, Entrant by S.. Jude Medical, Cardiac Rhythm Management Division PDF, 432KB, File does not meet accessibility standards 01. September 2023 Medical devices Customer information

Product group Active implantable medical devices – defibrillators Reference 24612/23

Urgent Field Safety Notice for Luminos dRF/Max;Agile Max;Ysio/Max/X.pree by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 1MB, File does not meet accessibility standards 01. September 2023 Medical devices Customer information

Product group Radiological technology – stationary radiological equipment Reference 25216/23

Urgent Field Safety Notice for Over-Ear headphones for different MAGNETOM MRI systems by Siemens Healthcare GmbH, Magnetic Resonance (MR) PDF, 2MB, File does not meet accessibility standards 30. August 2023 Medical devices Customer information

Product group Electromedical fields – equipment for MR tomography Reference 25043/23

Urgent Field Safety Notice for EasyFlow NCPAP Applikator by Fritz Stephan GmbH PDF, 215KB, File does not meet accessibility standards 30. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply Reference 22256/23

Urgent Field Safety Notice for Philips Allura Xper, Azurion and MultiDiagnost by Philips Medical Systems Nederland B.V PDF, 8MB, File does not meet accessibility standards 29. August 2023 Medical devices  Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics Reference 24891/23

Urgent Field Safety Notice for Over-Ear headphones for different MAGNETOM MRI systems by Siemens Healthcare GmbH, Magnetic Resonance (MR) PDF, 2MB, File does not meet accessibility standards 29. August 2023 Medical devices Customer information

Product group Electromedical fields – equipment for MR tomography Reference 25521/23

Urgent Field Safety Notice for Original Perfusor Line by B. Braun Melsungen AG PDF, 328KB, File does not meet accessibility standards 29. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology Reference 25501/23

Urgent Field Safety Notice for SOZO Bilateral Arm L-Dex Software by ImpediMed Limited PDF, 314KB, File does not meet accessibility standards 29. August 2023 Medical devices Customer information

Product group Medical data processing (software) – others Reference 25534/23

Urgent Field Safety Notice for FlurAbsorb by SedanaMedical Ltd Ireland PDF, 109KB, File does not meet accessibility standards 28. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply Reference 24608/23

Urgent Field Safety Notice for Apical Coring Knife by Thoratec Corporation PDF, 129KB, File does not meet accessibility standards 28. August 2023 Medical devices Customer information

Product group Active implantable medical devices – artificial hearts Reference 25366/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 1MB, File does not meet accessibility standards 28. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 23218/23

Urgent Field Safety Notice for Custom Tubing Set by Maquet Cardiopulmonary GmbH PDF, 2MB, File does not meet accessibility standards 25. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 24594/23

Urgent Field Safety Notice for Magnetic instrument pad by Medline International France SAS PDF, 614KB, File does not meet accessibility standards 25. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 25135/23

Urgent Field Safety Notice for MEDRAD Avanta Single Patient Administration Tubing by Bayer Medical Care Inc. PDF, 810KB, File does not meet accessibility standards 25. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology Reference 25110/23

Urgent Field Safety Notice for Infusomat Space by B. Braun Melsungen AG, Sparte Hospital Care PDF, 406KB, File does not meet accessibility standards 25. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology Reference 24295/23

Urgent Field Safety Notice for HUDSON RCI HUMIDIFIER ADAPTOR for use with AQUAPAK by Teleflex Medical USA PDF, 2MB, File does not meet accessibility standards 25. August 2023 Medical devices Customer information

Product group Physical therapy – inhalation therapy Reference 25140/23

Urgent Field Safety Notice for ARTIS PL E by Cristalens Industrie PDF, 1MB, File does not meet accessibility standards 24. August 2023 Medical devices Customer information

Product group Non-active implants – special implants Reference 24587/23

Urgent Field Safety Notice for AmiCORE Apheresis Kit by Fresenius Kabi AG PDF, 2MB, File does not meet accessibility standards 24. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells Reference 24471/23

Urgent Field Safety Notice for Palindrome by Covidien llc PDF, 307KB, File does not meet accessibility standards 24. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters Reference 25144/23

Urgent Field Safety Notice for Essenta DR Compact by Philips Medical Systems DMC GmbH PDF, 538KB, File does not meet accessibility standards 24. August 2023 Medical devices Customer information

Product group Radiological technology – stationary radiological equipment Reference 24626/23

Urgent Field Safety Notice for Quest Spectrum Drape for Open Surgery PG by Premier Guard Zhongshan Limited PDF, 314KB, File does not meet accessibility standards 22. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 24004/23

Urgent Field Safety Notice for Revogene by Meridian Bioscience, Inc. PDF, 582KB, File does not meet accessibility standards 22. August 2023 Medical devices Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems Reference 21965/23

Urgent Field Safety Notice for HeartMate Touch Kit by Thoratec Corporation PDF, 522KB, File does not meet accessibility standards 22. August 2023 Medical devices Customer information

Product group Active implantable medical devices – programming and control equipment Reference 22774/23

Urgent Field Safety Notice for Medfusion Model 3500; Medfusion Model 4000 by Smiths Medical ASD, lnc. PDF, 464KB, File does not meet accessibility standards 22. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology Reference 25060/23

Urgent Field Safety Notice for Attune Cementless Cruciate Retaining (CR) Femur by DePuy Ireland UC PDF, 1MB, File does not meet accessibility standards 22. August 2023 Medical devices Customer information

Product group Non-active implants – bone surgery Reference 24301/23

Urgent Field Safety Notice for Vanadis Core T21/T18/T13 Reagent Cartridge with Vanadis Extract Reaction Plates by Wallac Oy PDF, 462KB, File does not meet accessibility standards 22. August 2023 Medical devices Customer information

Product group In-vitro diagnostics – others Reference 23184/23

Urgent Field Safety Notice for HLS Set Advanced 5.0, HLS Set Advanced 7.0, by Maquet Cardiopulmonary GmbH PDF, 4MB, File does not meet accessibility standards 22. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 35354/22

Urgent Field Safety Notice for Myopia Master by OCULUS Optikgeräte GmbH PDF, 321KB, File does not meet accessibility standards 21. August 2023 Medical devices Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics Reference 23055/23

Urgent Field Safety Notice for HLS Kanüle PAL 1723; BO-PVL 2155; BO-PVL 2355 by Maquet Cardiopulmonary GmbH PDF, 2MB, File does not meet accessibility standards 21. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters Reference 20676/23

Urgent Field Safety Notice for elisa 300, elisa 500, elisa 600, elisa 800 by Löwenstein Medical Innovation GmbH & Co. KG Steinbach PDF, 165KB, File does not meet accessibility standards 21. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply Reference 22103/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 519KB, File does not meet accessibility standards 21. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 06833/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 519KB, File does not meet accessibility standards 21. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 23190/23

Urgent Field Safety Notice for EXCOR-Kanüle by Berlin Heart GmbH PDF, 3MB, File does not meet accessibility standards 21. August 2023 Medical devices Customer information

Product group Active implantable medical devices – artificial hearts Reference 23767/23

Urgent Field Safety Notice for Philips Allura Xper, Azurion and MultiDiagnost -E by Philips Medical Systems Nederland B.V PDF, 3MB, File does not meet accessibility standards 21. August 2023 Medical devices Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics Reference 23785/23

Urgent Field Safety Notice for CamAPS and mylife CamAPS by CamDiab Ltd PDF, 173KB, File does not meet accessibility standards 21. August 2023 Medical devices Customer information

Product group Medical data processing (software) – medical apps Reference 23168/23

Urgent Field Safety Notice for HAMILTON-T1/-C1 and -MR1 by Hamilton Medical AG PDF, 259KB, File does not meet accessibility standards 21. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply Reference 22629/23

Urgent Field Safety Notice for iCHAIR SKY by Meyra GmbH PDF, 179KB, File does not meet accessibility standards 18. August 2023 Medical devices Customer information

Product group Orthopaedic / Rehabilitation technology – mobility aids Reference 22253/23

Urgent Field Safety Notice for Afinion 2; Alere Afinion 2 by Abbott Diagnostics Technologies AS PDF, 191KB, File does not meet accessibility standards 18. August 2023 Medical devices Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products Reference 15908/23

Urgent Field Safety Notice for ADVIA Chemistry Iron_2 (IRON_2) Reagents by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 247KB, File does not meet accessibility standards 18. August 2023 Medical devices Customer information

Product group In-vitro diagnostics – immunological products Reference 24604/23

Urgent Field Safety Notice for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 1MB, File does not meet accessibility standards 17. August 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 23047/23

Urgent Field Safety Notice for CLAM-2030 CL/CLAM-2040 CL by Shimadzu Corporation PDF, 315KB, File does not meet accessibility standards 17. August 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 22311/23

Urgent Field Safety Notice for croBEE Real-Time PCR System by GeneProof, a.s. PDF, 1MB, File does not meet accessibility standards 17. August 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 20983/23

Urgent Field Safety Notice for Cardiosave Intraaortic Balloon Pump by Datascope Corp., Interventional Products Division PDF, 447KB, File does not meet accessibility standards 17. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 12376/23

Urgent Field Safety Notice for LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVE by Randox Laboratories Ltd PDF, 1MB, File does not meet accessibility standards 17. August 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 23780/23

Urgent Field Safety Notice for Erytra analyzer / Erytra Eflexis by Diagnostic Grifols SA PDF, 271KB, File does not meet accessibility standards 17. August 2023 Medical devices Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products Reference 23954/23

Urgent Field Safety Notice for Convey Guiding Catheter by PendraCare International B.V. PDF, 363KB, File does not meet accessibility standards 17. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 24137/23

Urgent Field Safety Notice for Stryker Advanced Cement Mixer System by Stryker Instruments-a division of Stryker Corp PDF, 598KB, File does not meet accessibility standards 16. August 2023 Medical devices Customer information

Product group Medical instruments for use in humans – bone surgery Reference 23590/23

Urgent Field Safety Notice for Angel cPRP Processing Set (EU) by Arthrex INC PDF, 221KB, File does not meet accessibility standards 16. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells Reference 23394/23

Urgent Field Safety Notice for POLYFILM by PEROUSE MEDICAL (IVRY LE TEMPLE) PDF, 359KB, File does not meet accessibility standards 16. August 2023 Medical devices Customer information

Product group Dressings / Pads – bandages Reference 24150/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 783KB, File does not meet accessibility standards 16. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 16918/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 559KB, File does not meet accessibility standards 16. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 23160/23

Urgent Field Safety Notice for exoplan by exocad GmbH 16. August 2023 Medical devices Customer information

Product group Medical data processing (software) – software for computer-based treatment Reference 25388/23

Urgent Field Safety Notice for SPiN Thoracic Navigation Systems & associating prd by Veran Medical Technologies, Inc. PDF, 779KB, File does not meet accessibility standards 15. August 2023 Medical devices Customer information

Product group Radiological technology – navigation systems Reference 23712/23

Urgent Field Safety Notice for EMBRACE 2 by Empatica S.r.L. PDF, 1MB, File does not meet accessibility standards 15. August 2023 Medical devices Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics Reference 23032/23

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 659KB, File does not meet accessibility standards 15. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 05800/23

Urgent Field Safety Notice for Henke-Ject by Henke-Sass, Wolf GmbH PDF, 3MB, File does not meet accessibility standards 14. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas Reference 21860/23

Urgent Field Safety Notice for Foliodrape Patient Drapes Protect Plus by PAUL HARTMANN AG PDF, 908KB, File does not meet accessibility standards 11. August 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 22655/23

Urgent Field Safety Notice for McGRATH MAC 2 Disposable Laryngoscope Blades by Covidien llc PDF, 890KB, File does not meet accessibility standards10. August 2023 Medical devices Customer information

Product group Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes) Reference 23951/23

Urgent Field Safety Notice for accucurv by Lutronic Corporation PDF, 1MB, File does not meet accessibility standards 10. August 2023 Medical devices Customer information

Product group Medical electronics / Electromedical devices – electrotherapy Reference 21285/23

Urgent Field Safety Notice for HBS2 MIDI DRILL BIT by Gebrüder Martin GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards 09. August 2023 Medical devices Customer information

Product group Medical instruments for use in humans – bone surgery Reference 23388/23

Urgent Field Safety Notice for Knee Scorpion by Arthrex INC PDF, 493KB, File does not meet accessibility standards 09. August 2023 Medical devices Customer information

Product group Medical instruments for use in humans – bone surgery Reference 23661/23

Urgent Field Safety Notice for Proclaim, Infinity by Abbott – Neuromodulation Division PDF, 160KB, File does not meet accessibility standards 08. August 2023 Medical devices Customer information

Product group Active implantable medical devices – biostimulators Reference 21486/23

Urgent Field Safety Notice for Disposale EMR Kit by Olympus Medical Systems Corp. PDF, 1MB, File does not meet accessibility standards 08. August 2023 Medical devices Customer information

Product group Optics / Precision engineering – endoscopes Reference 23396/23

Urgent Field Safety Notice for Set d’accouchement by PAUL HARTMANN AG PDF, 2MB, File does not meet accessibility standards 08. August 2023 Medical devices Customer information

Product group Medical instruments for use in humans – gynaecology Reference 22124/23

Urgent Field Safety Notice for Alphenix Biplane Angio by Canon Medical Systems Corporation PDF, 631KB, File does not meet accessibility standards 07. August 2023 Medical devices Customer information

Product group Radiological technology – stationary radiological equipment Reference 21487/23

Urgent Field Safety Notice for Pentacam AXL, Pentacam AXL Wave by OCULUS Optikgeräte GmbH PDF, 296KB, File does not meet accessibility standards 07. August 2023 Medical devices Customer information

Product group ophthalmological technology – equipment for ophthalmological diagnostics Reference 23054/23

Urgent Field Safety Notice for Babyroo TN300 by Draeger Medical Systems, Inc PDF, 616KB, File does not meet accessibility standards 07. August 2023 Medical devices Customer information

Product group Physical therapy – climatotherapy Reference 23346/23

Urgent Field Safety Notice for APERLAN POKA YOKE (Agent A & Agent B) by Getinge Disinfection AB PDF, 1MB, File does not meet accessibility standards 04. August 2023 Medical devices Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation Reference 21264/23

Urgent Field Safety Notice for Bronchofiberscope, Bronchovideoscope, Ultrasonic Bronchofibervideoscope, Tracheal Intubation Fiberscope, Tracheal Intubation Videoscope, Airway Mobilescope by Olympus Medical Systems Corp. PDF, 256KB, File does not meet accessibility standards 04. August 2023 Medical devices Customer information

Product group Optics / Precision engineering – endoscopes Reference 23181/23

Urgent Field Safety Notice for diverse by Medicrea International PDF, 985KB, File does not meet accessibility standards 04. August 2023 Medical devices Customer information

Product group Non-active implants – bone surgery Reference 20508/23

Urgent Field Safety Notice for PDS Plus Antibacterial (polydioxanone) Suture by Johnson & Johnson Int. PDF, 2MB, File does not meet accessibility standards 03. August 2023 Medical devices Customer information

Product group Dressings / Pads – surgical sutures, vascular loops etc. Reference 22649/23

Urgent Field Safety Notice for PDS II Suture by Ethicon, Inc. PDF, 625KB, File does not meet accessibility standards 03. August 2023 Medical devices Customer information

Product group Dressings / Pads – surgical sutures, vascular loops etc. Reference 22791/23

Urgent Field Safety Notice for Superelastic NiTi Archwire by GC Orthodontics Europe GmbH PDF, 450KB, File does not meet accessibility standards 02. August 2023 Medical devices Customer information

Product group Dental products – orthodontic equipment Reference 22290/23

Urgent Field Safety Notice for OCT. Spondy Schr. 6,0x45mm by Bricon GmbH PDF, 150KB, File does not meet accessibility standards 02. August 2023 Medical devices Customer information

Product group Non-active implants – bone surgery Reference 22634/23

Urgent Field Safety Notice for ERISMA LP EVO SCREW HEAD POSITIONER by CLARIANCE PDF, 592KB, File does not meet accessibility standards 02. August 2023 Medical devices Customer information

Product group Medical instruments for use in humans – bone surgery Reference 20355/23

Urgent Field Safety Notice for Kanüle geschlossen & seitliche Öffnungen, skaliert by S. Us Instruments GmbH PDF, 619KB, File does not meet accessibility standards 01. August 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas Reference 22472/23

Urgent Field Safety Notice for PASCAL ACE Implant System by Edwards Lifesciences LLC PDF, 162KB, File does not meet accessibility standards 31. July 2023 Medical devices Customer information

Product group Non-active implants – cardiac surgery Reference 21841/23

Urgent Field Safety Notice for Low Profile Screw, Cannulated, Partially Threaded 4.5 mm x 32 mm by Arthrex Inc. PDF, 553KB, File does not meet accessibility standards 31. July 2023 Medical devices Customer information

Product group Non-active implants – bone surgery Reference 19337/23

Urgent Field Safety Notice for SAFELIGHT FIBER OPTIC CABLE by Stryker Endoscopy-San Jose PDF, 452KB, File does not meet accessibility standards 31. July 2023 Medical devices Customer information

Product group Optics / Precision engineering – endoscopes Reference 13570/23

Urgent Field Safety Notice for fabian HFO, +nCPAP evolution and Therapy evolution by Acutronic Medical Systems AG PDF, 901KB, File does not meet accessibility standards 31. July 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply Reference 15618/21

Urgent Field Safety Notice for Trifecta Valve, Trifecta GT Valve by S.. Jude Medical, Costa Rica Ltd. (CS) PDF, 655KB, File does not meet accessibility standards 31. July 2023 Medical devices Customer information

Product group Non-active implants – cardiac surgery Reference 05804/23

Urgent Field Safety Notice for MassCheck Drugs of Abuse Testing Urine Control Set Level I by Chromsystems Instruments & Chemicals GmbH PDF, 864KB, File does not meet accessibility standards 27. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 17924/23

Urgent Field Safety Notice for G8 Elution Buffers HSi No.2 by Tosoh Corporation PDF, 193KB, File does not meet accessibility standards 27. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 20869/23

Urgent Field Safety Notice for Fusion Lithotripsy Extraction Basket by Cook Endoscopy PDF, 852KB, File does not meet accessibility standards 27. July 2023 Medical devices Customer information

Product group Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy Reference 19662/23

Urgent Field Safety Notice for Diacan Flex by B. Braun Avitum AG PDF, 225KB, File does not meet accessibility standards 27. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters Reference 20172/23

Urgent Field Safety Notice for TRIGEN TROCHANTERIC ANTEGRADE NAIL by Smith & Nephew, Inc., PDF, 79KB, File does not meet accessibility standards 27. July 2023 Medical devices Customer information

Product group Non-active implants – bone surgery Reference 22141/23

Urgent Field Safety Notice for RayCare 5A, 5B, 6A by RaySearch Laboratories AB PDF, 320KB, File does not meet accessibility standards 27. July 2023 Medical devices Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 21147/23

Urgent Field Safety Notice for Lead Clippers by Cook Vandergrift Inc. PDF, 721KB, File does not meet accessibility standards 26. July 2023 Medical devices Customer information

Product group Medical instruments for use in humans – general instruments Reference 20882/23

Urgent Field Safety Notice for Filter/HME TwinStar by Drägerwerk AG & Co. KGaA PDF, 436KB, File does not meet accessibility standards 26. July 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply Reference 21838/23

Urgent Field Safety Notice for Vantage Galan,Vantage Centurian,Vantage Titan by Canon Medical Systems Corporation PDF, 686KB, File does not meet accessibility standards 25. July 2023 Medical devices Customer information

Product group Electromedical fields – equipment for MR tomography Reference 21146/23

Urgent Field Safety Notice for Link OptiStem, Rasp Handle Stainless Steel by Waldemar Link GmbH & Co. KG PDF, 848KB, File does not meet accessibility standards 25. July 2023 Medical devices Customer information

Product group Medical instruments for use in humans – bone surgery Reference 21848/23

Urgent Field Safety Notice for 2 piece syringes – brand names: verschiedene by B. Braun Melsungen AG PDF, 381KB, File does not meet accessibility standards 25. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – syringes and cannulas Reference 21816/23

Urgent Field Safety Notice for EUROLINE Mediterrane Inhalation (IgE) by EUROIMMUN Medizinische Labordiagnostika AG PDF, 357KB, File does not meet accessibility standards 25. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – immunological products Reference 21672/23

Urgent Field Safety Notice for Symbia Pro.specta by Siemens Medical Solutions USA, Inc. Molecular Imaging PDF, 437KB, File does not meet accessibility standards 21. July 2023 Medical devices Customer information

Product group Radiological technology – CT scanners Reference 20871/23

Urgent Field Safety Notice for Tube set with suction/irrigation handle, single use by W.O.M. World of Medicine AG PDF, 573KB, File does not meet accessibility standards 21. July 2023 Medical devices Customer information

Product group Optics / Precision engineering – endoscopes Reference 21287/23

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 2MB, File does not meet accessibility standards 21. July 2023 Medical devices Customer information

Product group Active implantable medical devices – artificial hearts Reference 10797/22

Urgent Field Safety Notice for 3D9-3v Transducer by Philips Medical Systems – Ultrasound PDF, 1MB, File does not meet accessibility standards 21. July 2023 Medical devices Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment Reference 19402/23

Urgent Field Safety Notice for Advanta V12 Covered Stent by Atrium Medical Corporation Merrimack PDF, 202KB, File does not meet accessibility standards 21. July 2023 Medical devices Customer information

Product group Non-active implants – special implants Reference 19586/23

Urgent Field Safety Notice for NIV ANGLED MOUTHPIECE WITH NOTCH 22M/15F by Intersurgical Ltd. PDF, 461KB, File does not meet accessibility standards 21. July 2023 Medical devices Customer information

Product group Medical electronics / Electromedical devices – pulmonary function diagnostics Reference 20188/23

Urgent Field Safety Notice for CBC NUCOS by Kimetec GmbH PDF, 181KB, File does not meet accessibility standards 21. July 2023 Medical devices Customer information

Product group General equipment for medical treatment – medico-mechanical devices Reference 20504/23

Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 163KB, File does not meet accessibility standards 21. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 03483/23

Urgent Field Safety Notice for Aquilex Fluid Control System by W.O.M. World of Medicine AG PDF, 3MB, File does not meet accessibility standards 20. July 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 21162/23

Urgent Field Safety Notice for ACUSON Redwood by Siemens Medical Solutions USA, Inc., Ultrasound Division PDF, 1MB, File does not meet accessibility standards 20. July 2023 Medical devices Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment Reference 21008/23

Urgent Field Safety Notice for MobileLink Acetabular Cup System by Waldemar Link GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards 20. July 2023 Medical devices Customer information

Product group Non-active implants – bone surgery Reference 20886/23

Urgent Field Safety Notice for Ingenia Elition, MR 7700 by Philips Medical Systems Nederland B.V. PDF, 3MB, File does not meet accessibility standards 19. July 2023 Medical devices Customer information

Product group Electromedical fields – equipment for MR tomography Reference 31507/22

Urgent Field Safety Notice for DP30 by Nouvag AG PDF, 869KB, File does not meet accessibility standards 18. July 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 18577/23

Urgent Field Safety Notice for CUSTOM-PAK Surgical Procedure Pack by Alcon Laboratories, Inc. PDF, 541KB, File does not meet accessibility standards 18. July 2023 Medical devices Customer information

Product group Medical instruments for use in humans – eye surgery Reference 19629/23

Urgent Field Safety Notice for HOYA Vivinex multiSert IOL by HOYA Medical Singapore Pte.Ltd. PDF, 238KB, File does not meet accessibility standards 18. July 2023 Medical devices Customer information

Product group Non-active implants – special implants Reference 17180/23

Urgent Field Safety Notice for Minisart by Sartorius Stedim Biotech GmbH PDF, 648KB, File does not meet accessibility standards 18. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – filters Reference 19928/23

Urgent Field Safety Notice for Atellica CH Lithium_2 (LITH_2) + Atellica CH Lithium (Li) by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 117KB, File does not meet accessibility standards 18. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 25699/22

Urgent Field Safety Notice for S. smoke evacuation handle, NSTC by KLS Martin GmbH + Co. KG PDF, 1MB, File does not meet accessibility standards 17. July 2023 Medical devices Customer information

Product group Medical electronics / Electromedical devices – electrotherapy Reference 18058/23

Urgent Field Safety Notice for Artis one by Siemens Shenzhen Magnetic Resonance Ltd. PDF, 937KB, File does not meet accessibility standards 17. July 2023 Medical devices Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics Reference 08627/23

Urgent Field Safety Notice for CGM CLINICAL Medication by CompuGroup Medical Deutschland AG PDF, 581KB, File does not meet accessibility standards 17. July 2023 Medical devices Customer information

Product group Medical data processing (software) – others Reference 19828/23

Urgent Field Safety Notice for PLS Permanent Life Support Set by Maquet Cardiopulmonary AG PDF, 641KB, File does not meet accessibility standards 17. July 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 29022/22

Urgent Field Safety Notice for GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle by Creganna Medical PDF, 469KB, File does not meet accessibility standards 14. July 2023 Medical devices Customer information

Product group Medical instruments for use in humans – visceral surgery Reference 20661/23

Urgent Field Safety Notice for Access Folate (Reagent Pack) by Beckman Coulter, Inc. PDF, 1MB, File does not meet accessibility standards 14. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 19654/23

Urgent Field Safety Notice for Secura by Smith & Nephew Medical Ltd. PDF, 184KB, File does not meet accessibility standards 14. July 2023 Medical devices Customer information

Product group Dressings / Pads – ointments and gels Reference 20530/23

Urgent Field Safety Notice for Stericlin – Klarsichtbeutel aus Papier und Folie by Vereinigte Papierwarenfabriken GmbH PDF, 3MB, File does not meet accessibility standards 13. July 2023 Medical devicesCustomer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation Reference 19117/23

Urgent Field Safety Notice for Quidel Triage Cardiac Panel by Quidel Cardiovascular Inc. PDF, 383KB, File does not meet accessibility standards 13. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – immunological products Reference 19128/23

Urgent Field Safety Notice for HP5500D by Herco Wassertechnik GmbH PDF, 315KB, File does not meet accessibility standards 13. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – dialysis technology Reference 20503/23

Urgent Field Safety Notice for Alaris Gateway Workstation by BD Switzerland Sarl PDF, 1MB, File does not meet accessibility standards 13. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology Reference 19447/23

Urgent Field Safety Notice for Chevalier Valvulotome by LeMaitre Vascular, Inc. PDF, 160KB, File does not meet accessibility standards 13. July 2023 Medical devices Customer information

Product group Medical instruments for use in humans – vascular surgery Reference 20961/23

Urgent Field Safety Notice for ALLEGRA -Transcatheter Aortic Valve by NVT GmbH PDF, 2MB, File does not meet accessibility standards 12. July 2023 Medical devices Customer information

Product group Non-active implants – cardiac surgery Reference 19808/23

Urgent Field Safety Notice for Griffmodul V2.0, 5-times-use Morcellator System by Trokamed GmbH PDF, 144KB, File does not meet accessibility standards 12. July 2023 Medical devices Customer information

Product group Optics / Precision engineering – endoscopes Reference 15916/23

Urgent Field Safety Notice for Access TSH (3rd IS) Reagent by Immunotech PDF, 416KB, File does not meet accessibility standards 12. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – immunological products Reference 19824/23

Urgent Field Safety Notice for Diacon 3 Hematology Control by Diatron MI Zrt. PDF, 717KB, File does not meet accessibility standards 12. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products Reference 30415/22

Urgent Field Safety Notice for Bloplate I 1-10 by NORDIC BIOLABS AB PDF, 1MB, File does not meet accessibility standards 11. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – microbiological products Reference 18599/23

Urgent Field Safety Notice for Bloplate II 1-10 by NORDIC BIOLABS AB PDF, 1MB, File does not meet accessibility standards 11. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – microbiological products Reference 18600/23

Urgent Field Safety Notice for ORTHO Vision & Vision Max Analyzer by Ortho Clinical Diagnostics Inc. PDF, 310KB, File does not meet accessibility standards 11. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry Reference 18805/23

Urgent Field Safety Notice for MetaVision Suite, Clinical Information System& EHR by iMDsoft Ltd. PDF, 601KB, File does not meet accessibility standards 11. July 2023 Medical devices Customer information

Product group Medical data processing (software) – others Reference 18439/23

Urgent Field Safety Notice for SINGLE USE TROCAR SETS 10/12MM by Aesculap AG PDF, 3MB, File does not meet accessibility standards 11. July 2023 Medical devices Customer information

Product group Medical instruments for use in humans – visceral surgery Reference 20199/23

Urgent Field Safety Notice for IntelliVue MX400-550 by Philips Medizin Systeme Böblingen GmbH PDF, 2MB, File does not meet accessibility standards 11. July 2023 Medical devices Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics Reference 18280/23

Urgent Field Safety Notice for Microtrays Cyt 60 by NORDIC BIOLABS AB PDF, 1MB, File does not meet accessibility standards 11. July 2023 Medical devices Customer information

Product group In-vitro diagnostics – microbiological products Reference 18598/23

Urgent Field Safety Notice for INTESTINAL VIDEOSCOPE PSF-1 by Olympus Medical Systems Corp. PDF, 198KB, File does not meet accessibility standards 11. July 2023 Medical devices Customer information

Product group Optics / Precision engineering – endoscopes Reference 19611/23

Urgent Field Safety Notice for Diabecare DANA-i insulin pump by SOOIL Development Co. Ltd. PDF, 422KB, File does not meet accessibility standards 10. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology Reference 19101/23

Urgent Field Safety Notice for DynaMesh-IPST-R visible by FEG Textiltechnik Forschung- und Entwicklungsgesellschaft mbH PDF, 1,016KB, File does not meet accessibility standards 10. July 2023 Medical devices Customer information

Product group Non-active implants – special implants Reference 20020/23

Urgent Field Safety Notice for Medex extension s.t. by Smiths Medical ASD, lnc. PDF, 354KB, File does not meet accessibility standards 07. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology Reference 19826/23

Urgent Field Safety Notice for Fistura catheter by F Care Systems NV PDF, 208KB, File does not meet accessibility standards 06. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters Reference 13919/23

Urgent Field Safety Notice for CADD 50 mL and 100 mL Medication Cassette Reservoirs with Flow Stop when used with CADD-Legacy infusion pumps by Smiths Medical ASD, lnc. PDF, 956KB, File does not meet accessibility standards 05. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology Reference 31521/22

Urgent Field Safety Notice for MP Monoblock Hip System, Trial Stem by Waldemar Link GmbH & Co. KG PDF, 1MB, File does not meet accessibility standards 04. July 2023 Medical devices Customer information

Product group Medical instruments for use in humans – bone surgery Reference 19442/23

Urgent Field Safety Notice for TruSignal SPO2 sensors by GE Healthcare Finland Oy PDF, 949KB, File does not meet accessibility standards 04. July 2023 Medical devices Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics Reference 19327/23

Urgent Field Safety Notice for FIVE S. sterile, for single use by Karl Storz S. & Co KG PDF, 378KB, File does not meet accessibility standards 04. July 2023 Medical devices Customer information

Product group Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
Reference 19149/23

Urgent Field Safety Notice for Flow Re-Direction Endoluminal Device (FRED) by MicroVention,INC. PDF, 329KB, File does not meet accessibility standards 04. July 2023 Medical devices Customer information

Product group Non-active implants – special implants Reference 18770/23

Urgent Field Safety Notice for LifePort Kidney Transporter V1.1 by Organ Recovery Systems, Inc PDF, 245KB, File does not meet accessibility standards 04. July 2023 Medical devices Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment Reference 18576/23

Urgent Field Safety Notice for MAHURKAR Triple Lumen Catheter and MAHURKAR High Pressure Triple Lumen Catheter by Covidien llc PDF, 1MB, File does not meet accessibility standards 03. July 2023 Medical devices Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters Reference 18942/23