FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
- Recall number
- Z-1711-2020
- Recalling firm
- GE Healthcare, LLC
- Product
- Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
- Status
- Open, Classified
- Initiated
- 2019-12-03
- Posted
- 2020-04-24
- Terminated
- not on file
- 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 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.
- Quantity
- 123 in total
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- all affected systems
- 510(k) numbers
- ["K161682"]
- PMA numbers
- not on file
- Product code
- KGI
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28