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  1. Creganna Medical, TIP-23-001, GORE TIPS Set

    Gore has identified three lots of GORE TIPS Set devices that may be labeled with the incorrect expiration date. GORE TIPS Set ...

    Waarschuwing | 13-10-2023

  2. Boston Scientific Corporation, 98973760-FA, Guider Softip XF Guide catheters

    Stryker Neurovascular has observed that certain lots of Guider Softip™ XF Guide Catheters appear to have the incorrect tip curve ...

    Waarschuwing | 13-10-2023

  3. Randox Laboratories Ltd., REC692, Randox G6PDH

    Randox Laboratories voert een terugroepactie uit voor G-6-PDH-reagens, catalogusnummer PD410, batch 629055. Het R2 NADP- en ...

    Waarschuwing | 12-10-2023

  4. Waters Corporation, 1218959-09/27/2023-001-C, Waters Xevo TQ-S Micro IVD

    After investigation, a design vulnerability relating to firmware of Xevo TQ-S Micro IVD has been identified that, under specific ...

    Waarschuwing | 12-10-2023

  5. SENTINEL CH. S.p.A., 03/2023; FA02OCT2023, IRON, IRON, Alinity c Iron Reagent

    It has been identified that when using the ARCHITECT and Alinity c Iron products for the lots listed above, variable results can ...

    Waarschuwing | 12-10-2023

  6. Siemens Shenzhen Magnetic Resonance Ltd., MR078/23/S, Headband of the over-ear headphones

    This letter is to inform you about potential dot- or line-shaped artifacts caused by the presence of lubricating grease within ...

    Waarschuwing | 06-10-2023

  7. Medtronic Navigation, Inc., FA1361, Neuroscience CST - StealthStation™ S8 App version 2.0 and 2.0.1

    Medtronic heeft een softwareprobleem geïdentificeerd in de StealthStation™ S8-app, softwareversies 2.0 en 2.0.1 dat kan optreden ...

    Waarschuwing | 06-10-2023

  8. lmmunotech S.A.S. - A Beckman Coulter Company, 23043, Access hsTnI Reagent

    Beckman Coulter heeft vastgesteld dat er na de upgrade naar systeemsoftware 7.0.0 en hoger een restrisico op intratestoverdracht ...

    Waarschuwing | 05-10-2023

  9. Medeco B.V., FSN2023-01, Klinion Kliniray (Abdominal) Gauze Compress X-Ray

    After assessment of these products, it became known that x-ray threads in gauze compresses can disintegrate. It has been ...

    Waarschuwing | 05-10-2023

  10. TRUMPF Medizin Systeme GmbH Co. KG, FA-2023-047

    The potential impact for the missing IFU is that the users will not have awareness of appropriate use of the accessories, or ...

    Waarschuwing | 04-10-2023