Z-0449-2009

Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software

Name: Z-0449-2009 Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
Creator: Hologic, Inc.
Published: 2008-09-24
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2008-09-24 / Terminated / root cause: software

FDA source

Hologic, Inc. began a recall of Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software on 2008-09-24. The reason FDA records is "Software error may lead to a high estimate of major fracture probability". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0449-2009
Status: Terminated
Initiated: 2008-09-24
Posted: 2008-12-29
Terminated: 2016-03-07
Recalling firm: Hologic, Inc.
Product: Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
Product code: KGI Densitometer, Bone
Reason for recall: Software error may lead to a high estimate of major fracture probability.
Root cause tag: software
FDA 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 in commerce: 15 software discs
Distribution: Nationwide distribution in: CO, MA, MN, NM, NY, NC, OR, OH, PA, and TX. Also distributed in the UK.
Product codes and lots: Software Version: SFW-00700, Rev-002

Product code KGI

K080711Class II1.10-Year Fracture Risk Questionnaire Option for Qdr X-Ray Bone Densitometer, Model Qdr OptionHologic, Inc. / cleared 2008-09-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)