BEUDAMED
    FDA Recall Terminated

    GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.

    Recall: Z-2143-2008 · Initiated May 1, 2008

    Recall

    Recall Number
    Z-2143-2008
    Event Number
    49471
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    May 1, 2008
    Posted
    September 19, 2008
    Terminated
    December 17, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.

    Reason

    The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.

    Action

    GE Field Engineers visited affected customers to make the correction.

    Distribution

    Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,

    Quantity

    54 (24 US / 30 OUS)