BEUDAMED
    FDA Recall Terminated

    HiSpeed FX/I (2200997-2 with Gantry mo. #2200997)

    Recall: Z-0777-2011 · Initiated February 1, 2010

    Recall

    Recall Number
    Z-0777-2011
    Event Number
    56400
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    February 1, 2010
    Posted
    January 4, 2011
    Terminated
    May 21, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    HiSpeed FX/I (2200997-2 with Gantry mo. #2200997)

    Reason

    A defect with the hardware and software displaying the incorrect dose data.

    Action

    Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.

    Distribution

    Nationwide Distribution

    Quantity

    102 total