BEUDAMED
    FDA Enforcement Class II Ongoing

    SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.

    Recall: Z-0956-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0956-2024
    Event ID
    93787
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2024
    Initiation Date
    January 3, 2024
    Classification Date
    February 1, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296, United States

    Description

    SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.

    Reason

    The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

    Code Info

    a. Model No. 781270; UDI-DI 00884838095083. b. Model No. 782113; UDI-DI 00884838098909. c. Model No. 782129; UDI-DI 00884838105805. All units affected

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    21 US; 265 OUS