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
- Recall Number
- Z-2187-2008
- Event Number
- 48641
- Firm
- Hologic, Inc.
- FEI Number
- 1221300
- Product Code
- KGI
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- June 27, 2008
- Posted
- September 17, 2008
- Terminated
- October 25, 2010
- Address
- 35 Crosby Dr, Bedford, MA, 01730-1450
Description
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.
Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
Hologic notified customers by registered letter titled Urgent: Medical Device Recall, dated 6/27/08, providing instructions to update the software to Version 2.3 and discard version APEX 2.0, 2.1 and 2.2 manuals. If you have questions or require assistance with the software installation, contact Hologic's Help Desk at 1-800-321-4659.
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
325 units