—#86341

Product

DPX-MD series, 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.

FDA product code: KGI — Densitometer, Bone
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: software versions 12.0, 12.1, 12.2,13.0, & 13.1.

Why it was recalled

Failure to properly pre-indicate the technique factors to be used during a patient scan.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Ge Healthcare
Address: 9900 W Innovation Dr, Wauwatosa, Wisconsin 53226-4856

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2009-02-01
Posted by FDA: 2010-01-27
Terminated: 2011-12-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.