Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
FDA Recall Z-1712-2020 · Posted 2020-04-24
Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeKGI
Date Initiated2019-12-03
Product Quantity123 in total
Reason for Recall
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.