BEUDAMED
    FDA Enforcement Class II Terminated

    Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device

    Recall: Z-1240-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1240-2019
    Event ID
    82610
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems Nederlands
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2019
    Initiation Date
    March 25, 2019
    Classification Date
    April 26, 2019
    Termination Date
    June 4, 2020
    Address
    Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

    Description

    Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device

    Reason

    Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.

    Code Info

    US Serial Number: 47004 OUS Serial Numbers: 47001, 47002, 48000

    Distribution

    US Distribution to state of: FL and Internationally to: Switzerland and Germany.

    Quantity

    4 units