Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Biomet Orthopedic LLC, ZFA2022-00204, Oxford Fixed Lateral

    Biomet Orthopedics LLC is conducting a lot specific medical device Field Safety Corrective Action (removal) for certain Oxford ...

    Waarschuwing | 30-12-2022

  2. Bolton Medical Inc, 2247858-12-06-2022-001R, RelayPro Thoracic Stent Graft System

    The Efficia External Paddles are intended to be used with the Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators – by ...

    Waarschuwing | 30-12-2022

  3. Philips Goldway Shenzhen Industrial Inc., 2021-CC-EC-023-IR, Efficia External Paddles

    The Efficia External Paddles are intended to be used with the Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators – by ...

    Waarschuwing | 29-12-2022

  4. Philips Goldway Shenzhen Industrial Inc., 2022-CC-EC-010-IR, Efficia Pads Adapter Cable

    Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators are at risk of failed ECG monitoring, defibrillation, synchronized ...

    Waarschuwing | 29-12-2022

  5. INTRASENSE, FSN-2022-01 (Azure Ref: 26966), Myrian

    By default, Myrian® hides series of types scout, dose report and other documents to make the workspace clearer and only display ...

    Waarschuwing | 28-12-2022

  6. Safe Orthopaedics, FSN-22-03, CEMENT PUSHER KIT

    Safe Orthopedics has detected an anomaly concerning the instructions for use of the Cement Pushers and Kit Needle kits. The ...

    Waarschuwing | 28-12-2022

  7. Teleflex Malaysia Sdn Bdh Malaysia, FSN-EIF-000523, RUSCHELIT® Super Safety Clear Tracheal Tube, oral/nasal, Murphy - and others

    This voluntary FSCA for the above-listed products has been initiated due to reports of pilot balloon non-inflation or cuff ...

    Waarschuwing | 22-12-2022

  8. Osypka AG, FSCA_002_NCR_155_2022, Cardiac valvuloplasty catheter

    Based on customer feedback, we have determined that a mix-up occurred during the labelling process for these products.

    Waarschuwing | 21-12-2022

  9. Agfa HealthCare, VR0000758, Enterprise Imaging XERO Viewer

    Door een softwarefout, kunnen in Enterprise Imaging XERO in uitzonderlijke gevallen, beelden gepresenteerd worden die gekoppeld ...

    Waarschuwing | 21-12-2022

  10. Zimmer, ZFA2022-00240, NexGen Option Stemmed Tibial Component

    Zimmer, Inc. is conducting a voluntary medical device Field Safety Corrective Action (removal) related to the NexGen® Stemmed ...

    Waarschuwing | 21-12-2022