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Urgent Field Safety Notice for SONY by SONY Corporation PDF, 163KB, File does not meet accessibility standards Date: 27. July 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12628/21

Urgent Field Safety Notice for Prelude Short Sheath Introducer by Merit Medical Systems Inc. PDF, 378KB, File does not meet accessibility standards Date: 26. July 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 14586/21

Urgent Field Safety Notice for GORE®Molding and Occlusion Balloon Catheter by W.L. Gore & Associates, Inc. PDF, 51KB, File does not meet accessibility standards Date: 26. July 2021 Topics: Medical devices Type: Customer information

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

Urgent Field Safety Notice for Ovation iX by Endologix International Holdings B.V. PDF, 168KB, File does not meet accessibility standards Date: 26. July 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 06151/20

Urgent Field Safety Notice for GELITA-SPON RAPID3 by GELITA MEDICAL GmbH PDF, 260KB, File does not meet accessibility standards Date: 22. July 2021 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - ointments and gels
Reference 14063/21

Urgent Field Safety Notice for TruCal G6PDH, TruLab G6PDH by DiaSys Diagnostic Systems GmbH PDF, 447KB, File does not meet accessibility standards Date: 20. July 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 12611/21

Urgent Field Safety Notice for QStat® Cartridges by HemoSonics, LLC PDF, 95KB, File does not meet accessibility standards Date: 20. July 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 07287/21

Urgent Field Safety Notice for Combitrans Monitoring Set by B. Braun Melsungen AG Vascular Systems PDF, 86KB, File does not meet accessibility standards Date: 20. July 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electronic blood pressure monitor
Reference 14213/21

Urgent Field Safety Notice for cobas 6500/601 urine analyzer; cobas u 701 microscopy analyzer by Roche Diagnostics GmbH PDF, 301KB, File does not meet accessibility standards Date: 20. July 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10555/21

Urgent Field Safety Notice for ORG 903MX Anti-HSV-1 IgM Abs. by Orgentec Diagnostika GmbH PDF, 9MB, File does not meet accessibility standards Date: 19. July 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 13110/21

Urgent Field Safety Notice for ETEST IMIPENEM RELEBACTAM-WW & US by bioMérieux S. (Marcy- l'Etoile) PDF, 742KB, File does not meet accessibility standards Date: 19. July 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 13104/21

Urgent Field Safety Notice for cobas u pack by Roche Diagnostics GmbH PDF, 451KB, File does not meet accessibility standards Date: 19. July 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 12736/21

Urgent Field Safety Notice for BOND-MAX, BOND-III by Leica Biosystems Melbourne Pty Ltd PDF, 136KB, File does not meet accessibility standards Date: 19. July 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 13087/21

Urgent Field Safety Notice for VeriSeq NIPT Solution by Illumina, Inc. PDF, 2MB, File does not meet accessibility standards Date: 13. July 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 13974/21

Urgent Field Safety Notice for Kaluza C Software version 1.0 by Beckman Coulter, Inc. PDF, 103KB, File does not meet accessibility standards Date: 13. July 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 13852/21

Urgent Field Safety Notice for OEC Elite - OEC 3D by GE OEC Medical Systems, Inc. PDF, 103KB, File does not meet accessibility standards Date: 12. July 2021 Topics: Medical devices Type: Customer information

Product group Radiological technology - mobile radiological diagnostic facilities
Reference 13880/21

Urgent Field Safety Notice for Augentropfsystem ATS by Heinz Meise Medizintechnik GmbH PDF, 3MB, File does not meet accessibility standards Date: 12. July 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - liquid media for ophthalmological purposes
Reference 13973/21

Urgent Field Safety Notice for Saug-Polypenfallen S. / Suction Polyp Traps S. by Endo-Flex GmbH PDF, 200KB, File does not meet accessibility standards Date: 12. July 2021 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 13128/21

Urgent Field Safety Notice for Impactor, TLIF cage / twin peaks by SPINEWAY PDF, 3MB, File does not meet accessibility standards Date: 12. July 2021 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 13734/21

Urgent Field Safety Notice for Pall NANODYNE ELD Filter & Pall LIPIPOR TNA Filter by Pall Medical, A Division of Pall International Sarl PDF, 156KB, File does not meet accessibility standards Date: 12. July 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - filters
Reference 13735/21