BEUDAMED
    FDA Recall Terminated

    GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT. The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

    Recall: Z-2219-2009 · Initiated November 3, 2008

    Recall

    Recall Number
    Z-2219-2009
    Event Number
    51309
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 3, 2008
    Posted
    September 17, 2009
    Terminated
    July 12, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT. The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

    Reason

    GE Healthcare become aware of an incident which caused a slight patient injury during his unload following a prone-oriented scan on Ventri. Although clear safety instructions were not followed in this case, additional measures will be implemented in an effort to reduce the probability or repeat occurrence.

    Action

    GE Healthcare issued a "Product Safety Notification" dated January 2009 to consignees. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology & Radiologists/Cardiologists. The letter describes the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. A GE Field Engineer will visit each site and implement the correction. For further information, contact your local GE Healthcare service representative at 1-800-437-1171 (US or Canada) or 1-262-896-2890 (outside the US).

    Distribution

    Worldwide Distribution -- US (AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MS, MO, NE, NV, NH, NJ, NY, NC, OH,OK PA, RI,SC, TN, TX, UT, VA, WA, WI and WV), AUSTRALIA, BRAZIL CANADA, DENMARK, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NETHERLANDS, NORWAY,SWEDEN, SWITZERLAND, TURKEY and UNITED KINGDOM.

    Quantity

    308 (252 US, 57 OUS)