BEUDAMED
    FDA Recall Open, Classified

    CombiDiagnost R90 Software Version R1.0 and R1.1

    Recall: Z-2357-2021 · Initiated July 22, 2020

    Recall

    Recall Number
    Z-2357-2021
    Event Number
    88393
    Firm
    Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany
    FEI Number
    3003768251
    Product Code
    JAA
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 22, 2020

    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.

    Action

    Philips sent customers an Electronic Product Radiation Correction letter dated July 14, 2021. The letter identified the affected product, problem and actions to be taken. Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. For questions contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO70900051.

    Distribution

    US Nationwide Distribution

    Quantity

    322 systems; 66 in US