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Terminated

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

FDA Recall Z-0449-2009 · Posted 2008-12-29

Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeKGI
Date Initiated2008-09-24
Date Terminated2016-03-07
Product Quantity15 software discs

Reason for Recall

Software error may lead to a high estimate of major fracture probability.

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide distribution in: CO, MA, MN, NM, NY, NC, OR, OH, PA, and TX. Also distributed in the UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0807111.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTIONHologic, Inc. · 2008-09-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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