BEUDAMED
    FDA Recall Terminated

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    Recall: Z-2241-2012 · Initiated April 26, 2010

    Recall

    Recall Number
    Z-2241-2012
    Event Number
    62729
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    April 26, 2010
    Posted
    August 22, 2012
    Terminated
    August 22, 2012
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    Reason

    GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation.

    Action

    No customer communication took place. On April 26, 2010, GE began opening service cases for field engineers to begin replacing the snubber boards. This action has been completed as of October 29, 2010.

    Distribution

    Worldwide and Nationwide (USA) distribution.

    Quantity

    845 units