BEUDAMED
    FDA Recall Open, Classified

    Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

    Recall: Z-1710-2020 · Initiated December 3, 2019

    Recall

    Recall Number
    Z-1710-2020
    Event Number
    85466
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KGI
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    December 3, 2019
    Posted
    April 24, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

    Reason

    An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

    Action

    GE Healthcare notified customers via an Electronic Product Radiation Warning Letter dated March 13, 2020. The letter provided the following instructions. 1) Discontinue use of the start button on the control panel of the Lunar iDXA system to start a scan until a GE Representative can correct your system. 2) Disable the control panel start button in the enCORE software by following the below steps: " In enCORE, select menu item Tools> User Options. " Select the measure tab. " Uncheck the option "Allow Scanner Start Button to initiate a Measurement " " Press OK. 3) Start the patient scan from the measure screen of the enCORE software. GE Healthcare will correct all affected Lunar iDXA systems by inspecting and replacing, if necessary, the iDXA control panel at no cost to the customer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    US Nationwide Distribution

    Quantity

    123 in total