BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

    Recall: Z-0461-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0461-2023
    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 SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

    Reason

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

    Code Info

    Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US.

    Distribution

    US Nationwide.

    Quantity

    566 total