BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2354-2026 · Initiated May 1, 2026

    Recall

    Recall Number
    Z-2354-2026
    Event Number
    98940
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    MQB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 1, 2026
    Posted
    June 5, 2026
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    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.

    Action

    Philips Medical notified the single consignee on about 05/01/2026 via mailed letter. The consignee was notified of the issue, potential risk, and instructed to Stop using the Wall Stand VS2 immediately to ensure patient and user safety while Philips provides the Seismic Bucky Unit 2 (BU2) Skyplate kit, do not attempt to inspect, adjust, or install any mechanical components of the Wall Stand yourself, circulate this Urgent Medical Device Correction letter to all users of this device so that they are aware of the issue and associated impact, and complete and return the provided response form. A Philips representative will contact the consignee to schedule a time for a Field Service Engineer (FSE) to visit the site to install a hardware correction.

    Distribution

    US distribution to California.

    Quantity

    1 unit