BEUDAMED
    FDA Recall Terminated

    Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27.

    Recall: Z-0274-2008 · Initiated August 1, 2007

    Recall

    Recall Number
    Z-0274-2008
    Event Number
    47235
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 1, 2007
    Posted
    August 2, 2008
    Terminated
    September 10, 2008
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27.

    Reason

    Inaccurate cassette size display reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger film cassette is inserted into the table Bucky (replacing a smaller cassette) after a protocol is selected on the console, the collimator will not adjust to the larger cassette size. The collimator stays at the original smaller cassette size and allows the operator to take an exposure.

    Action

    Consignees were notified by two "Product Safety Notification" letters on July 10, 2007. Each letter addressed one of the two safety issues with the affected product. The letters provided safety instructions on how avoid the software error and informed users that their representative would contact them to schedule a visit for a software correction installation.

    Distribution

    Worldwide Distribution --USA including states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, ID, IL ,IN, LA, MA, MD, MI, MO,MS, NC, ND, NE, NH, NJ, NM, NV, OH,OK, OR, PA, SC, SD, TN, TX, UT, VA, VT and WA; USA territory of: PR and countries: EGYPT, SAUDI ARABIA, MACEDONIA, FRANCE and GREAT BRITAIN.

    Quantity

    101