BEUDAMED
    FDA Recall Terminated

    Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.

    Recall: Z-0003-2009 · Initiated February 14, 2008

    Recall

    Recall Number
    Z-0003-2009
    Event Number
    53158
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 14, 2008
    Posted
    September 22, 2009
    Terminated
    December 18, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.

    Reason

    GE Healthcare has recently become aware of an error in the generator software on the Revolution XR/d configured with HP 8200 PC consoles that reports a mAs reading that is higher than is actually exposed to patients.

    Action

    Consignees were sent a GE Healthcare "Product Safety Notification" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology, and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, and Contact Information.

    Distribution

    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, ID, IL, IN, LA, MA, MI, MO, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA, and WI and countries of Canada, China, Japan, Korea, and Taiwan.

    Quantity

    83 (63 USA, 20 OUS)