BEUDAMED
    FDA Recall Terminated

    GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the internal structure or organs of the entire body,

    Recall: Z-2225-2008 · Initiated March 28, 2008

    Recall

    Recall Number
    Z-2225-2008
    Event Number
    48689
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    March 28, 2008
    Posted
    September 11, 2008
    Terminated
    December 17, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the internal structure or organs of the entire body,

    Reason

    Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis.

    Action

    Customer Letter and Operator Manual addendum were sent directly to customers in August 2008. When the software correction is issued, GE Field Engineer will visit each site to implement the correction. (Not conducted yet)

    Distribution

    AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA,WI, and WV. Countries of Argentina Australia Austria Belgium Brazil Canada Chile China Czech Republic Denmark Finland France French Polynesia Germany Greece Hong Kong India Indonesia Ireland Israel Italy Japan Korea Kuwait Lebanon Malaysia Mexico Netherlands New Zealand Norway Peru Philippines Russia Saudi Arabia Singapore South Africa Spain Sweden Switzerland Taiwan Taiwan Thailand Turkey United Arab Emirates and United Kingdom.

    Quantity

    720 units (360 US / 360 OUS) estimate