Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of
FDA device recall Z-1725-2009 · posted 2009-08-25 · Terminated
Recall details
- Recalling firm
- Hologic, Inc.
- Reason for recall
- System may not turn off at the end of the x-ray and cause additional x-ray exposure
- Action taken
- Hologic issued an Urgent: Medical Device Recall customer notification letter, dated April 17, 2009, by certified mail to inform customers of the problem. With the notification letter, customers will receive the following: -Software version Apex 12.6.2, 2.3.2, or 2.4.2 -Instructions to upgrade their systems with the provided software and to verify the new version on the system as a confirmation that the software was successfully loaded. -New Operator's Manual for installations where the operating characteristics of the system have changed due to the software upgrade. For Customers with systems with software versions other than 12.6, 2.3, or 2.4: Customers were asked to upgrade their QDR software, return their old QDR software disk, and complete and return to Hologic the enclosed Confirmation of Notification.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KGI
- Quantity affected
- 1914 units total
- Distribution
- Worldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Nethe
- Date initiated
- 2009-04-07
- Date posted
- 2009-08-25
- Date terminated
- 2010-11-29
- 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 |