Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone min
FDA device recall Z-2186-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Hologic, Inc.
- Reason for recall
- Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KGI
- Quantity affected
- 82 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
- Date initiated
- 2008-06-27
- Date posted
- 2008-09-17
- Date terminated
- 2010-10-25
- Location
- Bedford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS (K072847) | Hologic, Inc. | 2008-03-28 |