Z-1710-2020Class II

Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

Name: Z-1710-2020 Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
Creator: GE Healthcare, LLC
Published: 2019-12-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-12-03 / Open, Classified

FDA source

GE Healthcare, LLC began a recall of Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer on 2019-12-03. FDA classified it as Class II and gives the reason as "An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1710-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-12-03
Posted: 2020-04-24
Recalling firm: GE Healthcare
Product: Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
Product code: KGI Densitometer, Bone
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.
FDA 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 in commerce: 123 in total
Distribution: US Nationwide Distribution
Product codes and lots: all affected systems

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1710-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1709-2020	Class II	Ongoing	FDA Mandated	2020-05-06	2020-04-24
Z-1710-2020	Class II	Ongoing	FDA Mandated	2020-05-06	2020-04-24
Z-1711-2020	Class II	Ongoing	FDA Mandated	2020-05-06	2020-04-24
Z-1712-2020	Class II	Ongoing	FDA Mandated	2020-05-06	2020-04-24

Product code KGI

K133664Class IIEncore Version 16 Software for Ge Lunar Dxa Bone DensitometersGe Medical Systems Ultrasound & Primary Care Diagn / cleared 2014-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)