BEUDAMED
    FDA Enforcement Class II Ongoing

    CombiDiagnost R90 Software Version R1.0 and R1.1

    Recall: Z-2357-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2357-2021
    Event ID
    88393
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Medical Systems Gmbh, DMC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    July 22, 2020
    Classification Date
    August 28, 2021
    Address
    Development And Manufacturing Ctr., Rontgenstr. 24-26, Hamburg, N/A, N/A, Germany

    Description

    CombiDiagnost R90 Software Version R1.0 and R1.1

    Reason

    Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.

    Code Info

    Model 706100

    Distribution

    US Nationwide Distribution

    Quantity

    322 systems; 66 in US