Recall Z-0449-2009
Hologic, Inc. · initiated September 24, 2008
Product
Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
Codes / lots: Software Version: SFW-00700, Rev-002
Reason for recall
Software error may lead to a high estimate of major fracture probability.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-0449-2009
- Initiated
- September 24, 2008
- Posted by FDA
- December 29, 2008
- Terminated
- March 7, 2016
- Product code
- KGI – Densitometer, Bone
- Quantity
- 15 software discs
- Distribution
- Nationwide distribution in: CO, MA, MN, NM, NY, NC, OR, OH, PA, and TX. Also distributed in the UK.
- Recalling firm
- Hologic, Inc., Bedford, MA