BEUDAMED
    FDA Enforcement Class II Ongoing

    DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

    Recall: Z-2354-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2354-2026
    Event ID
    98940
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2026
    Initiation Date
    May 1, 2026
    Classification Date
    June 5, 2026
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

    Reason

    System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.

    Code Info

    Model Number: 712035. UDI: (01)00884838090705(21)24861049. Lot Code: 24861049.

    Distribution

    US distribution to California.

    Quantity

    1 unit