BEUDAMED
    FDA Recall Terminated

    ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

    Recall: Z-0727-2021 · Initiated December 8, 2020

    Recall

    Recall Number
    Z-0727-2021
    Event Number
    87039
    Firm
    PHILIPS HOME HEALTHCARE SOLUTION
    FEI Number
    3016860078
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    December 8, 2020
    Posted
    January 28, 2021
    Terminated
    June 21, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

    Reason

    After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.

    Distribution

    Nationwide

    Quantity

    91