FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

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
Brand
Ge Healthcare
UPC
software versions 12.0, 12.1, 12.2,13.0, & 13.1.

Units Affected

1,764 total