Class 2 Device Recall Hologic

• Date Initiated by Firm: September 24, 2008
• Date Posted: December 29, 2008
• Recall Status: Terminated 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/ Manufacturer: Hologic, Inc.; 35 Crosby Dr; Bedford MA 01730
• For Additional Information Contact: Lida Reed; 781-999-7589
• Manufacturer Reason for Recall: Software error may lead to a high estimate of major fracture probability.
• FDA Determined 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.
• 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