Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
FDA device recall Z-0449-2009 · posted 2008-12-29 · Terminated
Recall details
- Recalling firm
- Hologic, Inc.
- Reason for recall
- Software error may lead to a high estimate of major fracture probability.
- Action taken
- Hologic notified customers by telephone on 9/23 and 24/08 and instructed them to not use the software. A customer notification letter was sent via FedEx to customers on September 25, 2008.The letter requested de-installation of the software and return of the software to Hologic in a pre-paid envelope.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KGI
- Quantity affected
- 15 software discs
- Distribution
- Nationwide distribution in: CO, MA, MN, NM, NY, NC, OR, OH, PA, and TX. Also distributed in the UK.
- Date initiated
- 2008-09-24
- Date posted
- 2008-12-29
- Date terminated
- 2016-03-07
- 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 |
|---|---|---|
| 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION (K080711) | Hologic, Inc. | 2008-09-02 |