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 Introducer Needle (PROSET PENCAN) by B. Braun Melsungen AG PDF, 190KB, File does not meet accessibility standards Date: 29. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – injection kits
Reference 39236/23

Urgent Field Safety Notice for Trilogy Evo, Trilogy Evo O2 by Respironics, Inc. Pittsburgh PDF, 330KB, File does not meet accessibility standards Date: 29. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 36070/23

Urgent Field Safety Notice for OPTEASE Retrievable VCF and retrieval Catheter by Cordis Cashel PDF, 231KB, File does not meet accessibility standards Date: 29. December 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 38801/23

Urgent Field Safety Notice for FLEXSelect Elastic Bands by FlexMedics PDF, 428KB, File does not meet accessibility standards Date: 28. December 2023 Topics: Medical devices Type: Customer information

Product group Dental products – others
Reference 39576/23

Urgent Field Safety Notice for Medfusion Syringe Infusion Pump by Smiths Medical ASD, lnc. PDF, 486KB, File does not meet accessibility standards Date: 28. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 38774/23

Urgent Field Safety Notice for SOLTIVE Single-use Laser Fibers by Gyrus ACMI Inc. PDF, 237KB, File does not meet accessibility standards Date: 27. December 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – laser technology
Reference 37294/23

Urgent Field Safety Notice for LP TALAR IMPACTOR INSERT by EXACTECH, Inc. PDF, 2MB, File does not meet accessibility standards Date: 27. December 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 38997/23

Urgent Field Safety Notice for SAFIL MESH by B. Braun Surgical S.A. PDF, 557KB, File does not meet accessibility standards Date: 27. December 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 39337/23

Urgent Field Safety Notice for Mölnlycke Procedure Trays containing Rhinotamp by Mölnlycke Health Care AB PDF, 2MB, File does not meet accessibility standards Date: 27. December 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 39428/23

Urgent Field Safety Notice for Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e by Maquet Critical Care AB PDF, 2MB, File does not meet accessibility standards Date: 23. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 37756/23

Urgent Field Safety Notice for Spectral CT 7500/China, Spectral CT on Rails by Philips Medical Systems Nederland B.V. PDF, 2MB, File does not meet accessibility standards Date: 23. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 38596/23

Urgent Field Safety Notice for Incidin OxyWipe S. Incidin OxyFoam S by Ecolab Deutschland GmbH PDF, 596KB, File does not meet accessibility standards Date: 23. December 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 36060/23

Urgent Field Safety Notice for BrightView, BrightView X, BrightView XCT by Philips Healthcare (Cleveland) PDF, 2MB, File does not meet accessibility standards Date: 22. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – equipment for nuclear medical functional and localisation diagnostics
Reference 38799/23

Urgent Field Safety Notice for Software VERIQA by PTW Freiburg, Physikalisch-Technische Werkstätten Dr. Pychlau GmbH PDF, 648KB, File does not meet accessibility standards Date: 22. December 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Reference 39125/23

Urgent Field Safety Notice for MEGADYNE MEGA SOFT UNIVERSAL AND UNIVERSAL PLUS REUSABLE PATIENT RETURN ELECTRODES by Megadyne Medical Products Inc. PDF, 165KB, File does not meet accessibility standards Date: 22. December 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 37602/23

Urgent Field Safety Notice for Dover 100% Silicone Foley Catheter by Covidien llc PDF, 371KB, File does not meet accessibility standards Date: 22. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 38244/23

Urgent Field Safety Notice for Omnipod 5 Controller by Insulet Corporation Acton PDF, 237KB, File does not meet accessibility standards Date: 22. December 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – medical apps
Reference 36257/23

Urgent Field Safety Notice for Synergy Cranial, StealthStation Cranial by Medtronic Navigation Inc. PDF, 434KB, File does not meet accessibility standards Date: 19. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – navigation systems
Reference 11920/23

Urgent Field Safety Notice for Ultrasound system type 2300 by B-K Medical A/S PDF, 273KB, File does not meet accessibility standards Date: 19. December 2023 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic diagnostic equipment
Reference 38429/23

Urgent Field Safety Notice for ProxiDiagnost N90, ProxiDiagnost upgrade by Philips Medical Systems DMC GmbH PDF, 752KB, File does not meet accessibility standards Date: 19. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 38582/23

Urgent Field Safety Notice for EZDilate Fixed Wire (Guided) Balloon by Gyrus ACMI, Inc. PDF, 202KB, File does not meet accessibility standards Date: 19. December 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 36335/23

Urgent Field Safety Notice for Disposable Pin by Medtronic Navigation Inc. PDF, 221KB, File does not meet accessibility standards Date: 19. December 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 37235/23

Urgent Field Safety Notice for Artis icono and Artis pheno by Siemens Healthcare GmbH Advanced Therapies PDF, 635KB, File does not meet accessibility standards Date: 19. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 38282/23

Urgent Field Safety Notice for LM150TD by Löwenstein Medical Technology GmbH + Co. KG, Hamburg PDF, 1MB, File does not meet accessibility standards Date: 19. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 38846/23

Urgent Field Safety Notice for Dispo Medical Insufflation tube within Mölnlycke Procedure Trays by Mölnlycke Health Care AB PDF, 1MB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Physical therapy – insufflation technique
Reference 37437/23

Urgent Field Safety Notice for elisa 300, elisa 500, elisa 600, elisa 800 by Löwenstein Medical Innovation GmbH & Co. KG Steinbach PDF, 245KB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 37611/23

Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH PDF, 300KB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 38136/23

Urgent Field Safety Notice for Scorpio, Duracon, PCA, Trident by Stryker Joint Replacement PDF, 282KB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 38057/23

Urgent Field Safety Notice for iCHAIR SKY by Meyra GmbH PDF, 133KB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – mobility aids
Reference 38126/23

Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH PDF, 306KB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 38145/23

Urgent Field Safety Notice for LINQ II Insertable Cardiac Monitor by Medtronic Inc PDF, 3MB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – programming and control equipment
Reference 33492/23

Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B.V. PDF, 977KB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 37962/23

Urgent Field Safety Notice for Atlan Family by Drägerwerk AG & Co. KGaA PDF, 837KB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 35842/23

Urgent Field Safety Notice for Sterile Procedure Trays by Medline International France SAS PDF, 238KB, File does not meet accessibility standards Date: 18. December 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – others
Reference 37976/23

Urgent Field Safety Notice for PROTIS Software Kit 2.0 incl Licenc by Siemens Healthcare Diagnostics Products GmbH PDF, 184KB, File does not meet accessibility standards Date: 16. December 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 07729/23

Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B.V. PDF, 1MB, File does not meet accessibility standards Date: 15. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 37973/23

Urgent Field Safety Notice for The Insides System by The Insides Company Limited PDF, 786KB, File does not meet accessibility standards Date: 15. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 36666/23

Urgent Field Safety Notice for Leica Biosystems Tissue processor by Leica Biosystems Nussloch GmbH PDF, 1MB, File does not meet accessibility standards Date: 15. December 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 34920/23

Urgent Field Safety Notice for Q98458 Nasenset including Nasal Tampon by ArcRoyal uc. an Owens and Minor Company PDF, 761KB, File does not meet accessibility standards Date: 14. December 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 37946/23

Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B.V. PDF, 1MB, File does not meet accessibility standards Date: 14. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 37937/23

Urgent Field Safety Notice for Olympus ETD PAA Premium by Miele & Cie. KG PDF, 220KB, File does not meet accessibility standards Date: 14. December 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 37470/23

Urgent Field Safety Notice for Randox Calibration Serum Level 3 by Randox Laboratories Ltd PDF, 7MB, File does not meet accessibility standards Date: 14. December 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 37229/23

Urgent Field Safety Notice for Cardiosave Intraaortic Balloon Pump by Datascope Corp., Interventional Products Division PDF, 213KB, File does not meet accessibility standards Date: 14. December 2023 Topics: Medical devices Type: Customer information

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

Urgent Field Safety Notice for RADIA Effector Universal Needle Holder by Asensus Surgical Italia S.r.l. PDF, 1MB, File does not meet accessibility standards Date: 13. December 2023 Topics: Medical devices Type: Customer information

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

Urgent Field Safety Notice for Vitalio, Ingenio, Advantio, Inliven, Intua, Invive, Accolade, Proponent, Essentio, Altrua, Visionist, Valitude by Boston Scientific CRM PDF, 487KB, File does not meet accessibility standards Date: 13. December 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – cardiac pacemakers
Reference 11055/21

Urgent Field Safety Notice for VALLEYLAB FT10 by Covidien llc PDF, 205KB, File does not meet accessibility standards Date: 13. December 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 35618/23

Urgent Field Safety Notice for Scoot Control by mo-Vis bv PDF, 739KB, File does not meet accessibility standards Date: 13. December 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – mobility aids
Reference 33762/23

Urgent Field Safety Notice for SP6000 Hyperbaric, VP7000 Hyperbaric by Arcomed AG PDF, 79KB, File does not meet accessibility standards Date: 13. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 31257/23

Urgent Field Safety Notice for Olympus Flexible Endoscopes by Olympus Medical Systems Corp. PDF, 1MB, File does not meet accessibility standards Date: 13. December 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 36212/23

Urgent Field Safety Notice for Limited Lots of Exactech Knee, Hip, Shoulder and Ankle by EXACTECH, Inc. PDF, 1MB, File does not meet accessibility standards Date: 08. December 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 36021/23

Urgent Field Safety Notice for NAVALIS by Qualimed Innovative Medizinprodukte GmbH PDF, 207KB, File does not meet accessibility standards Date: 08. December 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 37284/23

Urgent Field Safety Notice for Proclaim, Infinity by Abbott – Neuromodulation Division PDF, 212KB, File does not meet accessibility standards Date: 07. December 2023 Topics: Medical devices Type: Customer information

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

Urgent Field Safety Notice for R3 Acetabular Shell by Smith & Nephew, Inc., PDF, 110KB, File does not meet accessibility standards Date: 07. December 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 35762/23

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 2MB, File does not meet accessibility standards Date: 07. December 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 33193/23

Urgent Field Safety Notice for CODMAN VPV SYSTEM by Integra LifeSciences Corp. PDF, 297KB, File does not meet accessibility standards Date: 07. December 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 36982/23

Urgent Field Safety Notice for recomLine HIV-1 & HIV-2 by Mikrogen GmbH PDF, 364KB, File does not meet accessibility standards Date: 07. December 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 35943/23

Urgent Field Safety Notice for BD BACTEC MicroMGIT Calibration Vial by Becton, Dickinson and Company PDF, 449KB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 34918/23

Urgent Field Safety Notice for ASTOPAD System by Stihler Electronic GmbH PDF, 1MB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 36458/23

Urgent Field Safety Notice for Medfusion Model 3500 Syringe Infusion Pump by Smiths Medical ASD, lnc. PDF, 585KB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 36065/23

Urgent Field Safety Notice for Power Knee battery pack by Össur hf. PDF, 467KB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – prostheses (exoprostheses)
Reference 36722/23

Urgent Field Safety Notice for Medfusion Model 4000 Syringe Infusion Pump by Smiths Medical ASD, lnc. PDF, 3MB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 36066/23

Urgent Field Safety Notice for BrightView, BrightView X, BrightView XCT by Philips Healthcare (Cleveland) PDF, 2MB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – equipment for nuclear medical functional and localisation diagnostics
Reference 37008/23

Urgent Field Safety Notice for Carbomer Eye Gel (AACARB, AACOMER, PUROPTICS) by Indiana Ophthalmics LLP. PDF, 477KB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – liquid media for ophthalmological purposes
Reference 36207/23

Urgent Field Safety Notice for GM85 by Samsung Electronics Co. Limited PDF, 374KB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – mobile radiological diagnostic facilities
Reference 37094/23

Urgent Field Safety Notice for Spectral CT 7500 by Philips Medical Systems Nederland B.V. PDF, 3MB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 37006/23

Urgent Field Safety Notice for Flexible video bronchoscope, reusable by Olympus Medical Systems Corp. PDF, 238KB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 32312/23

Urgent Field Safety Notice for Katerakt-Set Uni Kiel (surgery s.t. by SENGEWALD Klinikprodukte GmbH PDF, 3MB, File does not meet accessibility standards Date: 06. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 34330/23

Urgent Field Safety Notice for Kieferhöhlenstanze, Galea-Federhaken, Gaumenhaken, Biopsie- und Fasszange, optiscdhe Schere, Arbeitseinsatz mit Lenkhebel by Karl Storz S. & Co KG PDF, 273KB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 35998/23

Urgent Field Safety Notice for AirFit N10/N20/F20/F20NV/F30/F30i-AirTouch N20/F20 by ResMed Ltd. PDF, 1MB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 34912/23

Urgent Field Safety Notice for Estradiol free in Saliva by Demeditec Diagnostics GmbH PDF, 1MB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 35484/23

Urgent Field Safety Notice for iWear dynamic 250ml by SOLEKO S.p.A. PDF, 480KB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – contact lenses
Reference 36481/23

Urgent Field Safety Notice for Dolomite Gloss by Invacare Rea AB PDF, 155KB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – daily living aids
Reference 34151/23

Urgent Field Safety Notice for Rhinotamp und Rhinotamp latexfrei by Vostra GmbH medical products PDF, 4MB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 36063/23

Urgent Field Safety Notice for different Pakket containing Klinion Kliniray by Mölnlycke Health Care AB PDF, 3MB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 35020/23

Urgent Field Safety Notice for VIDAS CK-MB by bioMérieux S. (Marcy- l’Etoile) PDF, 337KB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 35792/23

Urgent Field Safety Notice for Septodont Parcan N NaOCL 3% Sol by Inter-Med, Inc. PDF, 222KB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group Dental products – others
Reference 18994/23

Urgent Field Safety Notice for GLDH FS DGKC by DiaSys Diagnostic Systems GmbH PDF, 396KB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 34628/23

Urgent Field Safety Notice for SOPHIE by Fritz Stephan GmbH PDF, 397KB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 30137/23

Urgent Field Safety Notice for Standard and customer specific Combitrans/Combidyn by B. Braun Melsungen AG PDF, 1MB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electronic blood pressure monitor
Reference 33640/23

Urgent Field Safety Notice for VERITAS Advanced Infusion & Fluidics Packs by Johnson & Johnson Surgical Vision, Inc. PDF, 871KB, File does not meet accessibility standards Date: 05. December 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 16597/23

Urgent Field Safety Notice for Panorama 1.0T by Philips Medical Systems Nederland B.V. PDF, 571KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Electromedical fields – equipment for MR tomography
Reference 35494/23

Urgent Field Safety Notice for UNIVERSAL JOINT SCREWDRIVER by Stryker Leibinger GmbH & Co. KG PDF, 191KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 28863/23

Urgent Field Safety Notice for Turbo Elite Laser Atherectomy Catheter by Spectranetics Corporation PDF, 541KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 34603/23

Urgent Field Safety Notice for CamAPS and mylife CamAPS by CamDiab Ltd PDF, 50KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – medical apps
Reference 33608/23

Urgent Field Safety Notice for Sensis, Sensis Vibe Combo, Sensis Vibe Hemo by Siemens Healthcare GmbH, Advanced Therapies Angiographie PDF, 909KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 36101/23

Urgent Field Safety Notice for ETT Set with cuffed Murphy ETT intubation by Guangzhou AMK Medical Equipment Co., Ltd. PDF, 641KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 33070/23

Urgent Field Safety Notice for Endo-Model – Patella Glide Resection Guide, large by Waldemar Link GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 35772/23

Urgent Field Safety Notice for D-Clip Anlegezange by Peter Lazic GmbH PDF, 589KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 30902/23

Urgent Field Safety Notice for Merit Maestro, Merit Pursue, Fountain Infusion by Merit Medical Systems Inc. PDF, 304KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 34729/23

Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS PDF, 114KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 34598/23

Urgent Field Safety Notice for COROFLEX ISAR NEO by B. Braun Melsungen AG PDF, 362KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 33469/23

Urgent Field Safety Notice for SYNCHROMED II by Medtronic Inc PDF, 124KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – drug pumps
Reference 35775/23

Urgent Field Safety Notice for HYBRID / SONIC by BALT Extrusion PDF, 358KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 32979/23

Urgent Field Safety Notice for SureForm Stapler by Intuitive Surgical, Inc. PDF, 859KB, File does not meet accessibility standards Date: 04. December 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 03550/23

Urgent Field Safety Notice for Actim Partus Test by ActimOy PDF, 1MB, File does not meet accessibility standards Date: 01. December 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 34858/23

Urgent Field Safety Notice for Hudson RCI AQUAPAK Humidifier Adaptors by Teleflex Medical Morrisville PDF, 680KB, File does not meet accessibility standards Date: 01. December 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 26300/23

Urgent Field Safety Notice for Acrobat-i Vacuum Positioner System by Maquet Cardiovascular PDF, 323KB, File does not meet accessibility standards Date: 01. December 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – cardiac/thorax surgery
Reference 34306/23

Urgent Field Safety Notice for Urea FS by DiaSys Diagnostic Systems GmbH PDF, 355KB, File does not meet accessibility standards Date: 01. December 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 33791/23

Urgent Field Safety Notice for Master by Ardo medical GmbH PDF, 119KB, File does not meet accessibility standards Date: 30. November 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 35007/23

Urgent Field Safety Notice for Actim PROM Test, Actim PROM 1ngeni Test by ActimOy PDF, 933KB, File does not meet accessibility standards Date: 30. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 34856/23

Urgent Field Safety Notice for PPS Blutentnahmegerät by MediPac GmbH PDF, 487KB, File does not meet accessibility standards Date: 28. November 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Reference 35447/23

Urgent Field Safety Notice for Bard Mission Disposable Core Biopsy Kit by Bard Peripheral Vascular Inc. (BPV) PDF, 774KB, File does not meet accessibility standards Date: 24. November 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 35824/23

Urgent Field Safety Notice for aPTT Screen cobas t 600T, aPTT Lupus cobas t 600T, aPTT cobas t 600T by Roche Diagnostics GmbH PDF, 784KB, File does not meet accessibility standards Date: 24. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – haematological, histological and cytological products
Reference 18939/23

Urgent Field Safety Notice for Zöliakie DQ2 und DQ8 Reverser Haybridisierungskit by GenID GmbH PDF, 509KB, File does not meet accessibility standards Date: 24. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 32727/23

Urgent Field Safety Notice for Autocal by HUMAN Gesellschaft für Biochemica und Diagnostica mbH PDF, 70KB, File does not meet accessibility standards Date: 24. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 34473/23

Urgent Field Safety Notice for DRX-Revolution Mobile X-Ray System by Carestream Health Inc. PDF, 425KB, File does not meet accessibility standards Date: 23. November 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – mobile radiological diagnostic facilities
Reference 32514/23

Urgent Field Safety Notice for OSS Compress & Mini Compress Anchor Plugs by Biomet Orthopedics, LLC PDF, 2MB, File does not meet accessibility standards Date: 23. November 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 31869/23

Urgent Field Safety Notice for Hookup (accessory) by Medivators (Cantel Medical) PDF, 365KB, File does not meet accessibility standards Date: 23. November 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 35554/23

Urgent Field Safety Notice for DreamStation Go Auto by Philips Respironics, Inc. PDF, 127KB, File does not meet accessibility standards Date: 23. November 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 35292/23

Urgent Field Safety Notice for Guardian Sensor by Medtronic Minimed PDF, 323KB, File does not meet accessibility standards Date: 23. November 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electric blood glucose meters
Reference 34583/23

Urgent Field Safety Notice for HeartStart Intrepid by Philips Goldway (Shenzhen) Industrial Inc. PDF, 1MB, File does not meet accessibility standards Date: 22. November 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrotherapy
Reference 31993/23

Urgent Field Safety Notice for Luminos Fusion, Impulse, RF Classic, Select, Axiom Iconos MD, Axiom Iconos R100 by Siemens Shanghai Medical Equipment Ltd. (SSME) PDF, 601KB, File does not meet accessibility standards Date: 21. November 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – stationary radiological equipment
Reference 33829/23

Urgent Field Safety Notice for Sterile Skin Stapler (Acos) by Sunmedix Co., Ltd. PDF, 1,006KB, File does not meet accessibility standards Date: 21. November 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – general instruments
Reference 32161/23

Urgent Field Safety Notice for Oral Dosing Applicator 1 ml by Hubert De Backer PDF, 798KB, File does not meet accessibility standards Date: 20. November 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – dosing systems
Reference 34525/23

Urgent Field Safety Notice for Custom Tubing Set by Maquet Cardiopulmonary GmbH PDF, 5MB, File does not meet accessibility standards Date: 20. November 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 34354/23

Urgent Field Safety Notice for DxA 5000 Automation System by Beckman Coulter Biomedical GmbH PDF, 746KB, File does not meet accessibility standards Date: 17. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 16370/23

Urgent Field Safety Notice for MatrixMIDFACE Screws 4mm, 4 in clip by Synthes GmbH PDF, 962KB, File does not meet accessibility standards Date: 17. November 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 34728/23

Urgent Field Safety Notice for ORTHO Vision & Vision Max Analyzer by Ortho Clinical Diagnostics Inc. PDF, 441KB, File does not meet accessibility standards Date: 15. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 33186/23

Urgent Field Safety Notice for EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE by Olympus Medical Systems Corp. PDF, 141KB, File does not meet accessibility standards Date: 15. November 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – endoscopes
Reference 32630/23

Urgent Field Safety Notice for TruCal G6PDH by DiaSys Diagnostic Systems GmbH PDF, 752KB, File does not meet accessibility standards Date: 14. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 32841/23

Urgent Field Safety Notice for Joint prosthesis implantation kit, single-use by EOS imaging PDF, 303KB, File does not meet accessibility standards Date: 14. November 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 30459/23

Urgent Field Safety Notice for RAPIDPOINT 500 by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 213KB, File does not meet accessibility standards Date: 14. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 34344/23

Urgent Field Safety Notice for Procedure Packs (Kitpacks) with opthalm. scalpel (feather) by Lohmann und Rauscher GmbH & Co. KG PDF, 111KB, File does not meet accessibility standards Date: 14. November 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 34003/23

Urgent Field Safety Notice for BIOFIRE FILMARRAY TORCH by BioFire Diagnostics, LLC PDF, 341KB, File does not meet accessibility standards Date: 13. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 34155/23

Urgent Field Safety Notice for TC-I Reusable Tip Clip Sensor by Masimo Corporation PDF, 177KB, File does not meet accessibility standards Date: 10. November 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electrodiagnostics
Reference 28337/23

Urgent Field Safety Notice for Fa. Washer 800 by Groupe Sebbin SAS PDF, 474KB, File does not meet accessibility standards Date: 10. November 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 32039/23

Urgent Field Safety Notice for epoc NXS Host by Epocal, Inc. PDF, 322KB, File does not meet accessibility standards Date: 10. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 32626/23

Urgent Field Safety Notice for NIM TriVantage EMG Endotracheal Tube by Medtronic Xomed Inc. PDF, 784KB, File does not meet accessibility standards Date: 09. November 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 33949/23

Urgent Field Safety Notice for ORBIS Anesthesia by DH Healthcare GmbH PDF, 897KB, File does not meet accessibility standards Date: 08. November 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 32261/23

Urgent Field Safety Notice for Androstanediol-Glucuronide ELISA by LDN Labordiagnostika Nord GmbH & Co.KG PDF, 1MB, File does not meet accessibility standards Date: 08. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 33788/23

Urgent Field Safety Notice for SeQuent Neo by B. Braun Melsungen AG PDF, 267KB, File does not meet accessibility standards Date: 08. November 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 33503/23

Urgent Field Safety Notice for Philips Azurion, Philips Allura by Philips Medical Systems Nederland B.V. PDF, 412KB, File does not meet accessibility standards Date: 08. November 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 33472/23

Urgent Field Safety Notice for McGRATH MAC Videolaryngoskop by Aircraft Medical Limited Edinburgh PDF, 536KB, File does not meet accessibility standards Date: 08. November 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
Reference 30039/23

Urgent Field Safety Notice for Quantum TTC Biliary Dilation Catheter by Cook Endoscopy PDF, 1MB, File does not meet accessibility standards Date: 08. November 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – catheters
Reference 33291/23

Urgent Field Safety Notice for Custom Procedure Pack containing Klinion Kliniray by Pennine Healthcare PDF, 647KB, File does not meet accessibility standards Date: 06. November 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 33322/23

Urgent Field Safety Notice for BD CD11b APC by Becton, Dickinson and Company, BD Biosciences PDF, 417KB, File does not meet accessibility standards Date: 03. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 32657/23

Urgent Field Safety Notice for AMT Extention set with 3 stopococks manifold (HAHNBANK 3-FACH BLAU 180cm) by PMH-Produtos Médico Hospitalares, S.A. PDF, 444KB, File does not meet accessibility standards Date: 03. November 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 33476/23

Urgent Field Safety Notice for Brilliance CT Big Bore; Philips CT Big Bore by Philips Medical Systems Nederland B.V. PDF, 954KB, File does not meet accessibility standards Date: 02. November 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – CT scanners
Reference 31715/23

Urgent Field Safety Notice for Multiva 1.5T by Philips Healthcare (Suzhou) Co.,Ltd PDF, 2MB, File does not meet accessibility standards Date: 02. November 2023 Topics: Medical devices Type: Customer information

Product group Electromedical fields – equipment for MR tomography
Reference 32631/23

Urgent Field Safety Notice for PMH Infusion s.t.- AMT 0158 by PMH-Produtos Médico Hospitalares, S.A. PDF, 2MB, File does not meet accessibility standards Date: 02. November 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion kits
Reference 31080/23

Urgent Field Safety Notice for Cobalt XT/Cobalt/Crome ICDs/CRT-Ds/Claria MRI/Amplia MRI/Compia MRI/Viva/Brava CRT-Ds/Visia AF/Visia AF MRI/Evera/Evera MRI/Primo MRI/Mirro MRI ICDs by Medtronic Inc. PDF, 398KB, File does not meet accessibility standards Date: 02. November 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – defibrillators
Reference 13556/23

Urgent Field Safety Notice for AlloSeq Assign by CareDx Pty Ltd PDF, 743KB, File does not meet accessibility standards Date: 01. November 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – instruments, apparatuses and systems
Reference 31245/23

Urgent Field Safety Notice for Philips Intera, Achieva, Ingenia CX by PHILIPS HEALTHCARE FRANCE PDF, 2MB, File does not meet accessibility standards Date: 01. November 2023 Topics: Medical devices Type: Customer information

Product group Electromedical fields – equipment for MR tomography
Reference 32635/23

Urgent Field Safety Notice for Treatment Planning System HDRPlus, SagiPlan by Eckert & Ziegler BEBIG GmbH PDF, 3MB, File does not meet accessibility standards Date: 01. November 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – nuclear medical therapeutic equipment
Reference 31420/23

Urgent Field Safety Notice for synedra AIM by Synedra Information Technologies GmbH PDF, 362KB, File does not meet accessibility standards Date: 01. November 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 32468/23

Urgent Field Safety Notice for Centricity Universal Viewer; Universal Viewer by GE Healthcare PDF, 309KB, File does not meet accessibility standards Date: 01. November 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – data processing facilities for image processing
Reference 29368/23

Urgent Field Safety Notice for synedra AIM by Synedra Information Technologies GmbH PDF, 215KB, File does not meet accessibility standards Date: 01. November 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 32469/23

Urgent Field Safety Notice for ORBIS ICU-Manager by DH Healthcare GmbH PDF, 319KB, File does not meet accessibility standards Date: 31. October 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 31433/23

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 332KB, File does not meet accessibility standards Date: 30. October 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 31436/23

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 300KB, File does not meet accessibility standards Date: 30. October 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 31040/23

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 755KB, File does not meet accessibility standards Date: 30. October 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 30962/23

Urgent Field Safety Notice for ORBIS ICU-Manager by DH Healthcare GmbH PDF, 872KB, File does not meet accessibility standards Date: 30. October 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 32256/23

Urgent Field Safety Notice for DRX-Revolution Mobile X-Ray System by Carestream Health Inc. PDF, 293KB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – mobile radiological diagnostic facilities
Reference 31414/23

Urgent Field Safety Notice for Ammonia Ultra by SENTINEL CH. SpA PDF, 2MB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 29854/23

Urgent Field Safety Notice for Medistrip by Neuromedex GmbH PDF, 1MB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – vascular surgery
Reference 31313/23

Urgent Field Safety Notice for Digital Accelerators with XVI or iViewGT by Elekta Ltd PDF, 593KB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
Reference 31710/23

Urgent Field Safety Notice for ORBIS Anesthesia by DH Healthcare GmbH PDF, 348KB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 31435/23

Urgent Field Safety Notice for ID NOW Instrument by Abbott Diagnostics Scarborough, Inc. PDF, 853KB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 31880/23

Urgent Field Safety Notice for PRIME Plus, PRIME Plus Vet by Nova Biomedical PDF, 189KB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 31818/23

Urgent Field Safety Notice for Validity Control 3 by UTAK Laboratories PDF, 652KB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 30927/23

Urgent Field Safety Notice for exoplan by exocad GmbH PDF, 546KB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – software for computer-based treatment
Reference 32634/23

Urgent Field Safety Notice for RAPIDPOINT 500 / 500E Blood Gas System by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 174KB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 30295/23

Urgent Field Safety Notice for ORBIS Anesthesia by DH Healthcare GmbH PDF, 658KB, File does not meet accessibility standards Date: 27. October 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) – others
Reference 32183/23

Urgent Field Safety Notice for X-Walker by BORT Medical GmbH PDF, 2MB, File does not meet accessibility standards Date: 26. October 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – orthoses
Reference 32175/23

Urgent Field Safety Notice for LinScan, TwinScan by GME German Medical Engineering GmbH PDF, 158KB, File does not meet accessibility standards Date: 26. October 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – laser technology
Reference 31878/23

Urgent Field Safety Notice for Disposable Cerclage Tensioner by Arthrex Inc. PDF, 527KB, File does not meet accessibility standards Date: 26. October 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans – bone surgery
Reference 30783/23

Urgent Field Safety Notice for Phosphorus Inorganic, Molybdate by DIALAB GmbH PDF, 400KB, File does not meet accessibility standards Date: 26. October 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 31288/23

Urgent Field Safety Notice for FlexSys by GME German Medical Engineering GmbH PDF, 159KB, File does not meet accessibility standards Date: 24. October 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering – laser technology
Reference 31879/23

Urgent Field Safety Notice for Wash Buffer 1 by Chromsystems Instruments & Chemicals GmbH PDF, 1MB, File does not meet accessibility standards Date: 20. October 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – equipment / products for clinical chemistry
Reference 31564/23

Urgent Field Safety Notice for StealthStation S. Navigation by Medtronic Navigation Inc. PDF, 1MB, File does not meet accessibility standards Date: 18. October 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – navigation systems
Reference 29632/23

Urgent Field Safety Notice for BI-MENTUM PressFit cup 51 by SERF PDF, 1MB, File does not meet accessibility standards Date: 18. October 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 29867/23

Urgent Field Safety Notice for Standard Incision Scalpel by Feather Safety Razor Co. Ltd. Overseas Division PDF, 1MB, File does not meet accessibility standards Date: 18. October 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – equipment for ophthalmological therapeutics
Reference 30146/23

Urgent Field Safety Notice for Vivo 1, Vivo 2, Vivo 3 by Breas Medical AB PDF, 575KB, File does not meet accessibility standards Date: 17. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 31237/23

Urgent Field Safety Notice for ARTIS icono ceiling by Siemens Healthcare GmbH, Advanced Therapies Angiographie PDF, 1MB, File does not meet accessibility standards Date: 17. October 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – radiological equipment for vascular diagnostics
Reference 31223/23

Urgent Field Safety Notice for BD Alaris Pump Sets, Gravity, and Extension infusion s.t. by BD Switzerland Sarl PDF, 970KB, File does not meet accessibility standards Date: 16. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 31234/23

Urgent Field Safety Notice for Quantum Blue Anti-Infliximab by Bühlmann Laboratories AG PDF, 251KB, File does not meet accessibility standards Date: 13. October 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 30914/23

Urgent Field Safety Notice for Centricity PACS by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 203KB, File does not meet accessibility standards Date: 13. October 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Reference 29768/23

Urgent Field Safety Notice for Varisoft by Unomedical Infusion Devices A/S PDF, 794KB, File does not meet accessibility standards Date: 13. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 31079/23

Urgent Field Safety Notice for Mo.Ma Ultra Cerebral Protection Device by Medtronic Inc PDF, 134KB, File does not meet accessibility standards Date: 13. October 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – special implants
Reference 31078/23

Urgent Field Safety Notice for Unity Femoral CR Component Cemented Size 7 Right by Corin Medical Ltd. PDF, 497KB, File does not meet accessibility standards Date: 12. October 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants – bone surgery
Reference 29767/23

Urgent Field Safety Notice for Acumen IQ Sensor, FloTrac Sensor, TruWave DPT by Edwards Lifesciences LLC PDF, 2MB, File does not meet accessibility standards Date: 11. October 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – electronic blood pressure monitor
Reference 30158/23

Urgent Field Safety Notice for IRON, IRON, Alinity c Iron Reagent by SENTINEL CH. SpA PDF, 2MB, File does not meet accessibility standards Date: 11. October 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics – immunological products
Reference 29725/23

Urgent Field Safety Notice for Assurity, Endurity by Abbott Sylmar PDF, 176KB, File does not meet accessibility standards Date: 11. October 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – cardiac pacemakers
Reference 30738/23

Urgent Field Safety Notice for Instrument Arm Drape by Intuitive Surgical, Inc. PDF, 314KB, File does not meet accessibility standards Date: 10. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 30279/23

Urgent Field Safety Notice for Siluron 1000 and Siluron 2000 and SiluronXtra by Fluoron GmbH PDF, 339KB, File does not meet accessibility standards Date: 10. October 2023 Topics: Medical devices Type: Customer information

Product group ophthalmological technology – liquid media for ophthalmological purposes
Reference 30253/23

Urgent Field Safety Notice for Klinion Kliniray by Medeco B.V. Bleiswijk PDF, 294KB, File does not meet accessibility standards Date: 10. October 2023 Topics: Medical devices Type: Customer information

Product group Dressings / Pads – dressings
Reference 29871/23

Urgent Field Safety Notice for MEERA EU with/without Drive Unit by Maquet GmbH PDF, 696KB, File does not meet accessibility standards Date: 10. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 23983/23

Urgent Field Safety Notice for MiniMed 780G Insulin Pump by Medtronic Minimed PDF, 132KB, File does not meet accessibility standards Date: 09. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 30097/23

Urgent Field Safety Notice for Atrium Ocean Water Seal Chest Drain by Atrium Medical Corporation Merrimack PDF, 141KB, File does not meet accessibility standards Date: 09. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Reference 29371/23

Urgent Field Safety Notice for MAGIX 2 by New Live Mobilité PDF, 581KB, File does not meet accessibility standards Date: 09. October 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology – mobility aids
Reference 21804/23

Urgent Field Safety Notice for C3 CryoSonde by Inomed Medizintechnik GmbH, Emmendingen PDF, 130KB, File does not meet accessibility standards Date: 06. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 27975/23

Urgent Field Safety Notice for Sentiero, Sentiero Screening 2 by PATH MEDICAL GmbH PDF, 26KB, File does not meet accessibility standards Date: 06. October 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices – ENT equipment
Reference 29238/23

Urgent Field Safety Notice for SapphireT Multi-Therapy by Eitan Medical Ltd PDF, 568KB, File does not meet accessibility standards Date: 05. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – infusion technology
Reference 28149/23

Urgent Field Safety Notice for THUNDERBEAT by Olympus Medical Systems Corp. PDF, 332KB, File does not meet accessibility standards Date: 05. October 2023 Topics: Medical devices Type: Customer information

Product group Ultrasonics – ultrasonic therapeutic equipment
Reference 28691/23

Urgent Field Safety Notice for DESCOSEPT SENSITIVE WIPES by Dr.Schumacher Gmbh PDF, 746KB, File does not meet accessibility standards Date: 05. October 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment – cleaning / disinfection / sterilisation
Reference 07347/23

Urgent Field Safety Notice for Level 1 H-2 Pressure Chambers by Smiths Medical ASD, Inc. (Plymouth) is no. part of ICU Medical PDF, 946KB, File does not meet accessibility standards Date: 04. October 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Reference 16718/22

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 446KB, File does not meet accessibility standards Date: 04. October 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices – artificial hearts
Reference 21994/20

Urgent Field Safety Notice for Einweg-Patientenschlauchsysteme VENTcirc-MMT by WEINMANN Emergency Medical Technology GmbH + Co. KG PDF, 518KB, File does not meet accessibility standards Date: 02. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Reference 28316/23

Urgent Field Safety Notice for Zimmer Dermatome Blades by Zimmer Orthopaedic Surgical Products PDF, 1MB, File does not meet accessibility standards Date: 02. October 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia – surgical equipment
Reference 28443/23