GE Healthcare, LLC Lunar iDXA bone densitometer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lunar iDXA bone densitometer
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
all affected systems
Products Sold
all affected systems
GE Healthcare, LLC is recalling Lunar iDXA bone densitometer due to An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026