BEUDAMED
    FDA Recall Terminated

    OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.

    Recall: Z-0515-2007 · Initiated January 15, 2007

    Recall

    Recall Number
    Z-0515-2007
    Event Number
    37191
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 15, 2007
    Posted
    February 15, 2007
    Terminated
    December 9, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.

    Reason

    Uroview 2800 system with 3 Phase Power Distribution Box (Wonder Box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. .

    Action

    Consignees were notified by letter on 01/15/2007. Instructions were given to position and not move the dual monitors until inspection and correction by GE personnel. For the affected units with a 3 phase power distribution box, users were cautioned to ensure that the access door to the power box is completely closed when the unit is powered on to prevent a shock hazard.

    Distribution

    Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.

    Quantity

    277 units