BEUDAMED
    FDA Recall Terminated

    GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications.

    Recall: Z-2145-2008 · Initiated May 1, 2008

    Recall

    Recall Number
    Z-2145-2008
    Event Number
    49473
    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
    January 7, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications.

    Reason

    The Precision RXi 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 will visit affected customers to make correction.

    Distribution

    Within the US to include: AK, CO, IL, IN, LA, MA, MI, MS, NC, NJ, NY, PA, SC,TN, UT, VA, WA, and WI. OUS to include: Australia, Brazil, Canada, Colombia, Korea, Mexico, Philippines, Taiwan, Thailand, and Venezuela.

    Quantity

    61 (32 US / 29 OUS)