BEUDAMED
    FDA Enforcement Class I Ongoing

    BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;

    Recall: Z-0930-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0930-2024
    Event ID
    93767
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    December 15, 2023
    Classification Date
    February 2, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296, United States

    Description

    BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;

    Reason

    Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.

    Code Info

    All serial numbers are affected. No UDI-DI available for this product.

    Distribution

    Domestic distribution nationwide. International distribution worldwide.

    Quantity

    56 US; 46 OUS