BEUDAMED
    FDA Enforcement Class II Terminated

    OEC 9900 Elite. MDL Numbers: D148942, D155043

    Recall: Z-1060-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1060-2017
    Event ID
    76074
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE OEC Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    December 27, 2016
    Classification Date
    January 20, 2017
    Termination Date
    July 12, 2018
    Address
    384 N Wright Brothers Dr, N/A, Salt Lake City, UT, 84116-2862, United States

    Description

    OEC 9900 Elite. MDL Numbers: D148942, D155043

    Reason

    GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.

    Code Info

    Manufactured from Oct 2005 to present

    Distribution

    Worldwide including govt/VA/military and foreign consignees.

    Quantity

    26,256 total