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  1. PTW Freiburg, FSN-QR 168-2023, Software BeamAdjust

    In a relative calibration of the detector array, the algorithm takes the dose for each measurement chamber of the array from the ...

    Waarschuwing | 13-06-2023

  2. Intersurgical Ltd, FSN-414091, Superset Fixed Elbow Catheter Mount 22F-22M/15F

    We have received reports of the patient elbow disconnecting from the Superset tube in a number of products.

    Waarschuwing | 13-06-2023

  3. Allen Medical Systems Inc., FSN-FA-2023-024, Allen Advance Chest Support w/pad

    Baxter Healthcare Corporation is issuing a Recall for the Allen Advance Chest Support to inform customers of the potential for ...

    Waarschuwing | 13-06-2023

  4. PHILLIPS MEDICAL SYSTEMS, FSN-FSCA 2023-CC-HPM-014, IntelliVue MX40 Patient Monitor

    Philips is initiating an URGENT Field Safety Notice to remind customers to review the information in the lntellivue MX40 ...

    Waarschuwing | 13-06-2023

  5. Drägerwerk AG & Co. KGaA, FSN-PR130017, Oxylog 3000 plus

    During the course of our global market surveillance activities, we have become aware of instances where emergency and transport ...

    Waarschuwing | 08-06-2023

  6. Xiros Ltd., FSN-2023-001, Suture/needle passer

    Xiros has received feedback that there have been a small number of instances where the CC-Hook instrument has deformed during ...

    Waarschuwing | 08-06-2023

  7. Beckman Coulter, Inc., FSN-FA 23021, DxI 9000 Access Immunoassay Analyzer

    Beckman Coulter heeft vastgesteld dat de hierboven vermelde softwareversie van de DxI 9000 Access-immunoassay-analyser het aantal ...

    Waarschuwing | 08-06-2023

  8. Abbott Diagnostics Technologies AS, FSN-CAPA-00005233, Alere Afinion 2 Afinion 2

    Abbott has identified an issue related to overheating of Afinion 2 instruments with software version ≤ 21.13. 

    Waarschuwing | 08-06-2023

  9. EUREKA SRL LAB DIVISION, FSN-01/2023, Noradrenalina IVD, calibrator and control

    A thorough examination at customer site of the calibrator performance showed that the Noradrenaline values were overestimated.  ...

    Waarschuwing | 08-06-2023

  10. Altomed Limited, FSN-PR6, Damato Ruthenium Plaque Template

    Our international distributor informed us of a complaint they received from one of their customers. The CIB template (REF  ...

    Waarschuwing | 08-06-2023