BEUDAMED
    FDA Enforcement Class II Terminated

    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems

    Recall: Z-1469-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1469-2017
    Event ID
    76568
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE OEC Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    February 21, 2017
    Classification Date
    March 14, 2017
    Termination Date
    April 24, 2017
    Address
    384 N Wright Brothers Dr, N/A, Salt Lake City, UT, 84116-2862, United States

    Description

    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems

    Reason

    OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.

    Code Info

    OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.

    Distribution

    One consignee in CA.

    Quantity

    1