BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips MR 7700 System, Model Number 782120

    Recall: Z-0462-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0462-2023
    Event ID
    91195
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2022
    Initiation Date
    November 22, 2022
    Classification Date
    December 8, 2022
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Philips MR 7700 System, Model Number 782120

    Reason

    Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

    Code Info

    Model 782120: UDI-DI: 00884838104112; Serial Numbers: 65005 65006 65007 65008

    Distribution

    US Nationwide.

    Quantity

    566 total