Company:GE Healthcare
Date of Enforcement Report 2/3/2010
Class:ll
PRODUCT
1) 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. Recall # Z-0600-2010;
2) Prodigy 1-8 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. Recall # Z-0601-2010;
3) DPX-NT 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. Recall # Z-0602-2010;
4) 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. Recall # Z-0603-2010;
5) DPX-Bravo/Duo, 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. Recall # Z-0604-2010
REASON
Failure to properly pre-indicate the technique factors to be used during a patient scan.
RECALLING FIRM/MANUFACTURER
GE Healthcare, Wauwatosa, WI, by letter on November 2, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1764 units
DISTRIBUTION
Nationwide
