Recall Z-1709-2020 ยท KGI Densitometer, Bone
GE Healthcare, LLC
Lunar iDXA bone densitometer
| Date | Apr 24, 2020 (initiated Dec 3, 2019) |
| Status | Open, Classified |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| 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 |
| Quantity | 123 in total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052581 | LUNAR IDXA Ge Medical Systems Ultrasound and Primary Care Dia, Oct 20, 2005 |