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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.