BEUDAMED
    FDA Recall Terminated

    GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.

    Recall: Z-1302-06 · Initiated August 16, 2006

    Recall

    Recall Number
    Z-1302-06
    Event Number
    36099
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 16, 2006
    Posted
    September 30, 2006
    Terminated
    July 27, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.

    Reason

    X-ray systems could provide output which exceeds the 20 R/minute limit.

    Action

    Consignees were notified by certified letter on 08/14-15/2006.

    Distribution

    Worldwide

    Quantity

    8,266 units (US), 2,664 units (foreign)