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Urgent Field Safety Notice for Jelonet (5 cm x 5 cm) "EurimPharm" by Smith & Nephew Medical Ltd. PDF, 1MB, File does not meet accessibility standards Date: 22. June 2021 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 11321/21

Urgent Field Safety Notice for Dimension Vista High Sensitivity Troponin I Flex by Siemens Healthcare Diagnostics Inc. Newark PDF, 1MB, File does not meet accessibility standards Date: 21. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 11705/20

URGENT: FIELD SAFETY NOTICE Philips Respironics CPAP and Bi-Level PAP Devices PDF, 111KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11652/21

URGENT: FIELD SAFETY NOTICE Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models PDF, 111KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11651/21

Urgent Field Safety Notice for VivaDiag SARS-CoV-2 Ag Rapid Test by VivaChek Biotech (Hangzhou) Co., Ltd. PDF, 96KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05458A/21

Urgent Field Safety Notice for Anse sterili per inoculazione by APTACA S.p.A. PDF, 369KB, File does not meet accessibility standards Date: 17. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 08902/21

Urgent Field Safety Notice for Medtronic CoreValveTM EvolutTM R System, Medtronic CoreValveTM EvolutTM PRO System by Medtronic CoreValve, LLC PDF, 187KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 11768/21

Urgent Field Safety Notice for Atellica UAS 800 analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 42KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10300/21

Urgent Field Safety Notice for Sabouraud 2 agar (SAB2-T) by bioMérieux S. (Marcy- l'Etoile) PDF, 668KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 10319/21

Urgent Field Safety Notice for DiGeorge/VCFS N25 and 22q13.3 Deletion Probe by Cytocell Ltd PDF, 44KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 10528/21

Urgent Field Safety Notice for DiGeorge/VCFS TUPLE1 and 22q13.3 Deletion Probe by Cytocell Ltd PDF, 123KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 10527/21

Urgent Field Safety Notice for Randox NEFA (Non-esterified fatty acid) by Randox Laboratories Ltd PDF, 221KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10018/21

Urgent Field Safety Notice for Atellica CH 930, IM 1300, IM 1600 Analyzers by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 76KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09937/21

Urgent Field Safety Notice for Creatine Kinase-MB (CK-MB) by Beckman Coulter Ireland Inc. PDF, 141KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10068/21

Urgent Field Safety Notice for Freelite Human Kappa Free Kit on Roche Cobas by The Binding Site Group Limited PDF, 268KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10064/21

Urgent Field Safety Notice for E2A (TCF3) Breakapart by Cytocell Ltd PDF, 45KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10549/21

Urgent Field Safety Notice for TCL1 Breakapart Probe by Cytocell Ltd PDF, 43KB, File does not meet accessibility standards Date: 16. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10529/21

Urgent Field Safety Notice for ZytoChem-Plus HRP Kit, Broad Spectrum by Zytomed Systems GmbH PDF, 100KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10637/21

Urgent Field Safety Notice for BESA Research 7.1 September 2020 by BESA GmbH PDF, 178KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 10941/21

Urgent Field Safety Notice for Centricity High Acuity Critical Care by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 211KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 11343/21

Urgent Field Safety Notice for Affinity IV Birthing Bed by Hill-Rom Company, Inc. PDF, 502KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 10484/21

Urgent Field Safety Notice for INTUBE TRACHEAL TUBE, WIRE REINFORCED CUFFED, 7MM by Intersurgical Ltd. PDF, 45KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11074/21

Urgent Field Safety Notice for Vitalio, Ingenio, Advantio, Inliven, Intua, Invive, Accolade, Proponent, Essentio, Altrua, Visionist, Valitude by Boston Scientific CRM PDF, 511KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

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

Urgent Field Safety Notice for Einmal-Handwaschbürste ,steril by ROESER Medical GmbH (Essen) PDF, 777KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 11174/21

Urgent Field Safety Notice for Linear Cutter LLC by Ethicon Endo-Surgery, Inc. PDF, 339KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 09594/21

Urgent Field Safety Notice for M8 Lead Adaptor; S. Lead Adaptor by Nevro Corp PDF, 185KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 08899/21

Urgent Field Safety Notice for INTERCEPT Blood System for Plasma by Cerus Corporation PDF, 21KB, File does not meet accessibility standards Date: 14. June 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 10644/21

Urgent Field Safety Notice for CODMAN BACTISEAL EVD CATHETER SET by Integra LifeSciences Corp. PDF, 426KB, File does not meet accessibility standards Date: 11. June 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 16652/20

Urgent Field Safety Notice for Q-Flow by Merivaara Corporation PDF, 231KB, File does not meet accessibility standards Date: 11. June 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10979/21

Urgent Field Safety Notice for Valiant NavionTM Thoracic Stent Graft System by Medtronic Inc PDF, 169KB, File does not meet accessibility standards Date: 11. June 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 03223/21