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  1. R82 A/S PMS 2020 05 FSCA - Chest support rev 2

    Chest support has a small plastic plug placed in the centre pole tube. We have received feedback from market, that plastic plug ...

    Waarschuwing | 04-03-2020

  2. RaySearch Laboratories AB FSN 56089 - RayStation

    Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by ...

    Waarschuwing | 03-03-2020

  3. Sysmex 672100072 - UF-5000 and UF-4000 Urine Analyzers

    It is reported that Sysmex UF-5000/UF-4000 with software versions 00-21 or 00-22 generated false PMN / MN results (false low PMN ...

    Waarschuwing | 03-03-2020

  4. Promedon S.A #455 - CAPA N°; MDSS ref. MDD20.022 - VANTRIS VUR Treatment

    Obstruction of the UVJ is a known but rare complication of any endoscopic treatment using bulking agents for the treatment of ...

    Waarschuwing | 01-03-2020

  5. Dentsply Sirona_Maillefer Instruments HHE 2020-1 - Finger Spreaders

    During a domestic inspection, Dentsply Sirona has detected a sporadic dimensional issue on a production of Finger Spreaders D ...

    Waarschuwing | 28-02-2020

  6. Siemens ACHC20-07 - Atellica CH Ethyl Alcohol (ETOH) assay

    Siemens Healthcare Diagnostics Inc. investigation has confirmed that the Atellica CH ETOH assay may exhibit a positive bias in QC ...

    Waarschuwing | 28-02-2020

  7. Medtronic FA906 - Pipeline Flex Embolization Device

    Medtronic has identified the potential for device fracture at the distal section during use due to a weakened bond in a subset of ...

    Waarschuwing | 27-02-2020

  8. Siemens Healthcare Diagnostics Inc ASW20-03 Atellica CH 930 Analyzer

    Editing an assay Test Definition and switching to another assay’s Test Definition screen without saving the changes using the ...

    Waarschuwing | 27-02-2020

  9. Momo Medical FSCA-2020-01 - Momo BedSense

    Door middel van deze brief laten wij u weten dat Momo Medical B.V. heeft besloten het  beoogd gebruik van de Momo BedSense, ...

    Waarschuwing | 26-02-2020

  10. Siemens PH-20-006 - Dade Ci-Trol 1

    Siemens Healthcare Diagnostics has observed that assigned confidence intervals for Fibrinogen are broader than expected. This ...

    Waarschuwing | 26-02-2020