Company: Hologic, Inc.,
Date of Enforcement Report 10/15/2008
Class:ll
PRODUCT
a) Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured
variables obtained from a given 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-2184-2008;
b) Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured
variables obtained from a given 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-2185-2008;
c) Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given 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-2186-2008;
d) Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given 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-2187-2008;
e) Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given 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-2188-1991
REASON
Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
RECALLING FIRM/MANUFACTURER
Hologic, Inc., Bedford, MA, by letter dated June 27, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,168 units
DISTRIBUTION
Nationwide and Internationally
