Recall Z-2184-2008 ยท KGI Densitometer, Bone
Hologic, Inc.
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.
| Date | Sep 17, 2008 (initiated Jun 27, 2008) |
| Status | Terminated |
| Reason | Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 534 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, Taiwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072847 | APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS Hologic, Inc., Mar 28, 2008 |