Class 2 Device Recall Hologic Oasis Bone Densitometers

• Date Initiated by Firm: June 27, 2008
• Date Posted: September 17, 2008
• Recall Status: Terminated on October 25, 2010
• Recall Number: Z-2188-1991
• Recall Event ID: 48641
• 510(K)Number: K072847
• Product Classification: Bone densitometer - Product Code KGI
• Product: Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
• Code Information: S/N: 11/01/06 B 1/04/08B 11/01/06 A 6/24/05-A 9/25/06-01 9/25/06-02 9/25/06-03 9/25/06-04 9/28/06-01 9/28/06-02 9/28/06-03 9/12/07B 10/02/07B 10/02/07A and 1/04/08A
• Recalling Firm/ Manufacturer: Hologic, Inc.; 35 Crosby Dr; Bedford MA 01730-1450
• For Additional Information Contact: Lida Reed; 781-999-7300
• Manufacturer Reason for Recall: Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
• FDA Determined Cause: Software design
• Action: Hologic notified customers by registered letter titled Urgent: Medical Device Recall, dated 6/27/08, providing instructions to update the software to Version 2.3 and discard version APEX 2.0, 2.1 and 2.2 manuals. If you have questions or require assistance with the software installation, contact Hologic's Help Desk at 1-800-321-4659.
• Quantity in Commerce: 15 units
• Distribution: Nationwide Foreign: Canada Algeria, AE, Australia, Belgium,China,France, Germany, Hungary, Hong Kong, Iceland, Iran, Ireland, Israel, Italy,Japan,Korea, Kuwait, Lithuania, Mexico, Myanmar, Netherlands, Pakistan, Peru, Russia, S. Africa, Saudi Arabia, Singapore, Slovak Rep., Switzerland, Syria, Taiwan, 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