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U.S. Department of Health and Human Services

Class 2 Device Recall Hologic

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  Class 2 Device Recall Hologic see related information
Date Initiated by Firm September 24, 2008
Date Posted December 29, 2008
Recall Status1 Terminated 3 on March 07, 2016
Recall Number Z-0449-2009
Recall Event ID 49712
510(K)Number K080711  
Product Classification bone fracture estimate software - Product Code KGI
Product Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
Code Information Software Version: SFW-00700, Rev-002
Recalling Firm/
Hologic, Inc.
35 Crosby Dr
Bedford MA 01730
For Additional Information Contact Lida Reed
Manufacturer Reason
for Recall
Software error may lead to a high estimate of major fracture probability.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KGI and Original Applicant = HOLOGIC, INC.