Recall Z-2188-1991
Hologic, Inc. · initiated June 27, 2008
Product
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.
Codes / lots: 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
Reason for recall
Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-2188-1991
- Initiated
- June 27, 2008
- Posted by FDA
- September 17, 2008
- Terminated
- October 25, 2010
- Product code
- KGI – Densitometer, Bone
- Quantity
- 15 units
- Distribution
- 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
- Recalling firm
- Hologic, Inc., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2184-2008 | Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2185-2008 | Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2186-2008 | Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |
| Z-2187-2008 | Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is…Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. | 06/27/2008Terminated |