BEUDAMED
    FDA Recall Terminated

    System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.

    Recall: Z-1130-2021 · Initiated December 17, 2020

    Recall

    Recall Number
    Z-1130-2021
    Event Number
    87089
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    December 17, 2020
    Terminated
    January 9, 2023
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.

    Reason

    GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.

    Action

    The manufacturer sent an "Urgent Medical Device Correction" letter (GEHC Ref# 25496) to customers with affected systems on 12/17/2020.

    Distribution

    Worldwide - US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NV, NY, NH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV; In the countries of Algeria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Denmark, Estonia, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (Republic Of), Kuwait, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam.

    Quantity

    1115 units