BEUDAMED
    FDA Recall Completed

    Revolution CT

    Recall: Z-2004-2021 · Initiated March 19, 2021

    Recall

    Recall Number
    Z-2004-2021
    Event Number
    88150
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Completed
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 19, 2021
    Posted
    July 8, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Revolution CT

    Reason

    GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

    Action

    GE Healthcare will perform an initial site assessment and replace the collimator, if needed. This will be followed by bi-weekly remote monitoring of the system s log file. Finally, GE Healthcare will install a currently under development software patch, added to the daily fast calibration to automatically and reliably detect this failure should it occur. All of these actions will be performed at no cost to the customer. For questions call 262-544-3217.

    Distribution

    Worldwide distribution - US Nationwide

    Quantity

    197 (US = 40; OUS = 157)