Device Recall Hologic Oasis Bone Densitometers

S/N: 11/01/06 B 1/04/08B 11/01/06 A 6/24/05-A 9/25/06-01 9/25/06-02 9/25/06-03 9/25/06-04 9/28/06-01 9/28/06-02 9/28/06-03 9/12/07B 10/02/07B 10/02/07A and 1/04/08A

Radiology Devices

2

No

Nationwide Foreign: Canada Algeria, AE, Australia, Belgium,China,France, Germany, Hungary, Hong Kong, Iceland, Iran, Ireland, Israel, Italy,Japan,Korea, Kuwait, Lithuania, Mexico, Myanmar, Netherlands, Pakistan, Peru, Russia, S. Africa, Saudi Arabia, Singapore, Slovak Rep., Switzerland, Syria, Taiwan, UK

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.