—#181017

Product

Lunar iDXA bone densitometer

FDA product code: KGI — Densitometer, Bone
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052581
Affected lot / code info: all affected systems

Why it was recalled

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

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2019-12-03
Posted by FDA: 2020-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.