BEUDAMED
    FDA Recall Open, Classified

    System, Tomography Computed Emmission

    Recall: Z-2258-2020 · Initiated November 30, 2018

    Recall

    Recall Number
    Z-2258-2020
    Event Number
    85746
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    November 30, 2018
    Posted
    June 3, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    System, Tomography Computed Emmission

    Reason

    GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.

    Action

    GE Healthcare identified that a small number of Nuclear Medicine systems are operating without currently updated software.

    Distribution

    Domestic Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, IA, IL, IN, KY, LA,MA, MD, ME, MI, MN, MO, MS, NC, NE, NM, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT,VA, WI and WV. Foreign Distribution: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Ghana, India, Israel, Italy, Japan, Korea, Malaisya, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Sweden, Taiwan, Thailand, Turkey and United Kingdom.

    Quantity

    526 total units