FDA Medical Device Recalls (openFDA)
Hologic, Inc.: Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
- Recall number
- Z-0449-2009
- Recalling firm
- Hologic, Inc.
- Product
- Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
- Status
- Terminated
- Initiated
- 2008-09-24
- Posted
- 2008-12-29
- Terminated
- 2016-03-07
- Reason
- Software error may lead to a high estimate of major fracture probability.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 15 software discs
- Distribution
- Nationwide distribution in: CO, MA, MN, NM, NY, NC, OR, OH, PA, and TX. Also distributed in the UK.
- Lot, serial or model codes
- Software Version: SFW-00700, Rev-002
- 510(k) numbers
- ["K080711"]
- PMA numbers
- not on file
- Product code
- KGI
- Firm FEI
- 1221300
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28