BEUDAMED
    FDA Recall Terminated

    LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11 gantry. For head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    Recall: Z-0669-2010 · Initiated October 1, 2009

    Recall

    Recall Number
    Z-0669-2010
    Event Number
    54178
    Firm
    Ge Healthcare
    FEI Number
    3005860720
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    October 1, 2009
    Posted
    February 2, 2010
    Terminated
    December 10, 2011
    Address
    9900 W Innovation Dr, Wauwatosa, WI, 53226-4856

    Description

    LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11 gantry. For head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    Reason

    Failure to properly document the CTDI in the Technical Reference or User Manual.

    Action

    GE is sending an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect, identify the affected product details, provide instructions, state the product correction, and the necessary contact information.

    Distribution

    Nationwide Distribution -- Including states of CT, SD, VA, WA, MA, PA, GA, IL, CA, MD, NY, NC, SC, AZ, TX, MT, FL, OH, OK, MI, CO, ME, WV, TN, KS, and WI.

    Quantity

    111 units total