BEUDAMED
    FDA Recall Open, Classified

    Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    Recall: Z-1951-2019 · Initiated January 19, 2019

    Recall

    Recall Number
    Z-1951-2019
    Event Number
    83254
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 19, 2019
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    Reason

    Additional low dose radiation exposure.

    Action

    GE Healthcare will send a customer letter that provide safety instructions for immediate mitigation of the issue. The customer can continue to use the system with the recommended workaround instruction provided in the customer letter: All affected systems will be corrected with updated software and a User Manual Addendum which re-emphasizes existing pat ient center ing instructions. If you have any questions or concerns regarding this notification. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide - US Nationwide Distribution

    Quantity

    857 (US = 195: OUS = 662)