Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
This recall has been terminated (originally issued December 29, 2008).
- Company
- Hologic, Inc.
- Recall Initiated
- September 24, 2008
- Posted
- December 29, 2008
- Terminated
- March 7, 2016
- Recall Number
- Z-0449-2009
- Quantity
- 15 software discs
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Software error may lead to a high estimate of major fracture probability.
Distribution
Nationwide distribution in: CO, MA, MN, NM, NY, NC, OR, OH, PA, and TX. Also distributed in the UK.
Lot / Code Info
Software Version: SFW-00700, Rev-002
Root 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.
More recalls by Hologic, Inc.
Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x
The device is a Mini C-arm Fluroscop...
May 17, 2013
Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2
The device is a Mini C-arm...
May 17, 2013
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1
The device is a...
Sep 25, 2012