Lunar iDXA bone densitometer
FDA device recall Z-1709-2020 · posted 2020-04-24 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- KGI
- Quantity affected
- 123 in total
- Distribution
- US Nationwide Distribution
- Date initiated
- 2019-12-03
- Date posted
- 2020-04-24
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUNAR IDXA (K052581) | Ge Medical Systems Ultrasound and Primary Care Dia | 2005-10-20 |