BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1469-2017 · Initiated February 21, 2017

    Recall

    Recall Number
    Z-1469-2017
    Event Number
    76568
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 21, 2017
    Posted
    February 27, 2017
    Terminated
    April 24, 2017
    Address
    384 N Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    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.

    Action

    On February 21, 2017, an Urgent Medical Device Correction letter was sent to one consignee with an affected unit; a field service representative hand delivered the customer communication.

    Distribution

    One consignee in CA.

    Quantity

    1