BEUDAMED
    FDA Enforcement Class II Terminated

    Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System

    Recall: Z-0928-2019 · Reported March 6, 2019

    Enforcement

    Recall Number
    Z-0928-2019
    Event ID
    82038
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems Nederlands
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2019
    Initiation Date
    December 21, 2018
    Classification Date
    February 22, 2019
    Termination Date
    November 19, 2020
    Address
    Veenpluis 4-6, Best, N/A, Netherlands

    Description

    Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System

    Reason

    There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

    Code Info

    All systems

    Distribution

    U.S. Nationwide distribution.

    Quantity

    11226 total