BEUDAMED
    FDA Recall Terminated

    GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.

    Recall: Z-2221-2012 · Initiated October 19, 2007

    Recall

    Recall Number
    Z-2221-2012
    Event Number
    62798
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 19, 2007
    Posted
    August 17, 2012
    Terminated
    August 17, 2012
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.

    Reason

    X-ray units did not meet manufacturer's specification for linearity.

    Action

    GE updated their user manual and changed their internal specifications to match those of the CFR In addition, a software code correction was to be made to forward productions in order to correct the reported defect. *** This recall issued was previously classified under an incorrect recall number. It is being reclassified with a new number. ***

    Distribution

    Worldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada.

    Quantity

    175 units