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U.S. Department of Health and Human Services

Class 2 Device Recall Hologic Delphi Bone Densitometers

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  Class 2 Device Recall Hologic Delphi Bone Densitometers see related information
Date Initiated by Firm June 27, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on October 25, 2010
Recall Number Z-2186-2008
Recall Event ID 48641
510(K)Number K072847  
Product Classification Bone densitometer - Product Code KGI
Product Hologic Delphi 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: 70411W 70456W 71132C 71132C 71205W 70007C 70024C 70102C 70129C 70138C 70351C 70379A 70394A 70395C 70414A 70415A 70418A 70419A 70421A 70434W 70512A 70525W 70545W 70561W 70603W 70609C 70677C 70678W 70717C 70721W 70724A 70734A 70744C 70761C 70791C 70817W 70824C 70845C 70855SL 70896SL 70987W 71016C 71035W 71076C 71091C 71151C 71172SL 71188C 71223C 71231W 71239C 71255W 71257C 71287C 71342C and 71386C 
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 2		 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 82 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 and Original Applicant = HOLOGIC, INC.
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