BEUDAMED
    FDA Enforcement Class II Terminated

    ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

    Recall: Z-0727-2021 · Reported February 3, 2021

    Enforcement

    Recall Number
    Z-0727-2021
    Event ID
    87039
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PHILIPS HOME HEALTHCARE SOLUTION
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    February 3, 2021
    Initiation Date
    December 8, 2020
    Classification Date
    December 31, 2020
    Termination Date
    June 21, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289, United States

    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.

    Code Info

    Pending

    Distribution

    Nationwide

    Quantity

    91