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  1. Zimmer Switzerland Manufacturing GmbH, ZFA2023-00237, Biolox® Option

    One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length ...

    Waarschuwing | 10-11-2023

  2. Siemens Healthcare GmbH, MR072/23/S, Over-ear headphones

    In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or ...

    Waarschuwing | 10-11-2023

  3. Illumina, Inc., FSN-QI – 00632, NextSeq 550Dx Instrument / MiSeq Dx Instrument

    Illumina heeft een kwetsbaarheid in de cybersecurity aangetroffen die van toepassing is op de Local Run Manager (LRM)-software in ...

    Waarschuwing | 10-11-2023

  4. Siemens Healthcare GmbH, AX036/23/S (FSCA), AX035/23/S (FSN), Cios

    With respect to DIN 6862-3: So far, in 3D mode, information about image orientation regarding “laterality” (i.e., L = left / R = ...

    Waarschuwing | 10-11-2023

  5. Maquet Cardiopulmonary GmbH, 879551, CARDIOHELP-i

    The IFU of the CARDIOHELP system states incorrect factory settings. The device itself is working as intended and the error only ...

    Waarschuwing | 10-11-2023

  6. Full Vision Inc, FSCA 20230519, Trackmaster Treadmills

    When given a start command from the integrated controller or attached stress system, the Drive and Motor is intended ...

    Waarschuwing | 10-11-2023

  7. Unomedical a.s, MA-2023-01, Varisoft

    Unomedical a/s heeft vastgesteld dat de connector van de VariSoft-infusieset in zeldzame gevallen gemakkelijker dan verwacht ...

    Waarschuwing | 10-11-2023

  8. Philips Healthcare, 2023-PD-MR-014, Philips Intera, Achieva, Ingenia CX

    Fabrikant: Philips Healthcare Product: Philips Intera, Achieva, Ingenia CX Datum FSN: 7-11-2023 Waarschuwing van fabrikant Dit ...

    Waarschuwing | 10-11-2023

  9. QuidelOrtho (Ortho Clinical Diagnostics Inc), CL2023-250, ORTHO VISION and VISION Max Analyzers for BioVue

    During an internal review, QuidelOrtho identified that Test ID 10023 included a calculated Rh (Anti-D or RhD) Interpretation ...

    Waarschuwing | 09-11-2023

  10. Abbott Molecular, Inc., FA-AM-OCT2023-293, Alinity m HCV AMP Kit

    Abbott has identified an increase in potential for reactive negative controls as well as separate instances of false positive ...

    Waarschuwing | 09-11-2023

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