Z-0600-2010

iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1...

Name: Z-0600-2010 iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1...
Creator: Ge Healthcare
Published: 2009-02-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-02-01 / Terminated

FDA source

Ge Healthcare began a recall of iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD on 2009-02-01. The reason FDA records is "Failure to properly pre-indicate the technique factors to be used during a patient scan". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0600-2010
Status: Terminated
Initiated: 2009-02-01
Posted: 2010-01-27
Terminated: 2011-12-31
Recalling firm: GE Healthcare
Product: iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD
Product code: KGI Densitometer, Bone
Reason for recall: Failure to properly pre-indicate the technique factors to be used during a patient scan.
FDA root cause: Radiation Control for Health and Safety Act
Action: An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions.
Quantity in commerce: 1,764 total
Distribution: Nationwide Distribution
Product codes and lots: software versions 12.0, 12.1, 12.2,13.0, & 13.1.

Product code KGI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)