Cl Il GE Lunar DEXA bone densitometers

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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