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  1. Natus Medical_Otometrics - ICS Chartr EP 200

    It has been determined that the device does not fully meet current regulatory standard for basic electrical safety and essential ...

    Waarschuwing | 17-06-2019

  2. Siemens Healthcare GmbH - CT035/19/S - SOMATOM Force, Drive, Confidence and more

    This letter is to inform you about four safety related software issues we have identified in the current syngo CT VB1OA software ...

    Waarschuwing | 14-06-2019

  3. Philips, FSCA 86100188A-IR, HeartStart MRx Defibrillator/Monitor

    Philips heeft vastgesteld dat de M3539A netvoedingsmodule voor de HeartStart MRxmonitor/defibrillator mogelijk sneller defect kan ...

    Waarschuwing | 12-06-2019

  4. Teleflex EIF-000354 - Hudson RCI Air Cushion Face Mask

    Teleflex roept vrijwillig de hierboven genoemde producten terug omdat ze een verkeerde CE-markering bevatten. Apparaten die DINP ...

    Waarschuwing | 12-06-2019

  5. Ad-Tech Medical 11-06-2019-00001 - Cortical Electrode, Depth Electrode, Anchor Bolt

    Ad-Tech Medical Instrument Corporation is recalling supplemental information that may have been sent to customers in response to ...

    Waarschuwing | 11-06-2019

  6. Bio-Rad_DiaMed GmbH FSCA 004-19 - DiaClon Rh-Subgroups + K

    Further to customer's reports, we have been able to confirm that interference can be observed in the anti-e microtube with QC ...

    Waarschuwing | 11-06-2019

  7. MEDICREA INTERNATIONAL - MAT 2019-11 - cervical cages (IMPIX MANTA, IMPIX MANTA+, IMPIX C and C-Curve) and lumbar cages (IMPIX-L)

    Titanium radiopaque markers were placed in cages instead of Tantalum markers. The objective of these markers is to verify the ...

    Waarschuwing | 11-06-2019

  8. Biomet UK Ltd - ZFA 2019-00103 - Biolox Hip Option Taper Adapter

    Biomet UK Ltd. is conducting a medical device Field Safety Corrective Action (removal) for specific lots of Biolox Hip Option ...

    Waarschuwing | 11-06-2019

  9. Becton Dickinson and Company, PAS-19-1454, BD Microtainer® Tubes

    BD is overgegaan tot een corrigerende veiligheidsmaatregel om specifieke lots van de BD Microtainer® buizen uit omloop te nemen ...

    Waarschuwing | 11-06-2019

  10. Abbott Diagnostics FA10JUN2019 - Alinity ci-series System Control Module

    Abbott has identified an issue with all on‐market versions of Alinity ci‐series Software where reuse of reaction vessels (RVs) ...

    Waarschuwing | 10-06-2019