Company:Hologic Inc.
Date of Enforcement Report 10/7/2009
Class:ll
PRODUCT
1) Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1725-2009;
2) Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1726-2009;
3) Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1727-2009;
4) Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1728-2009
REASON
System may not turn off at the end of the x-ray and cause additional x-ray exposure.
RECALLING FIRM/MANUFACTURER
Hologic, Inc., Bedford, MA, by letter dated April 17, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1914 units
DISTRIBUTION
Nationwide and Internationally
