Company: Hologic, Inc
Date of Enforcement Report 12/31/2008
Class:ll

PRODUCT
Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software, Recall # Z-0449-2009

REASON
Software error may lead to a high estimate of major fracture probability.

RECALLING FIRM/MANUFACTURER
Hologic, Inc., Bedford , MA , by telephone on September 23-24, 2008 and by letter on September 25, 2008. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
15 software CD’s

DISTRIBUTION
CO, MA, MN, NM, NY, NC, OR, OH, PA, TX, and UK