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U.S. Department of Health and Human Services

Class 2 Device Recall Hologic QDR 4500

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 Class 2 Device Recall Hologic QDR 4500see related information
Date Initiated by FirmApril 07, 2009
Date PostedAugust 25, 2009
Recall Status1 Terminated 3 on November 29, 2010
Recall NumberZ-1727-2009
Recall Event ID 51692
510(K)NumberK072847 
Product Classification Bone Densitometer - Product Code KGI
ProductHologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR 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: 45264A 45260A 45214A 45241A 45036A 47585C 49124C/CE 47513C 47758C 48342C/NCE 48337C/NCE 49781C/CE 48137C/NCE 47262C 45425SL/CE 45251SL 45751SL/CE 45815SL/CE, and  49521W/CE. 
Recalling Firm/
Manufacturer		 Hologic, Inc.
35 Crosby Dr
Bedford MA 01730
For Additional Information Contact
781-999-7300
Manufacturer Reason
for Recall		System may not turn off at the end of the x-ray and cause additional x-ray exposure
FDA Determined
Cause 2		Component design/selection
ActionHologic issued an Urgent: Medical Device Recall customer notification letter, dated April 17, 2009, by certified mail to inform customers of the problem. With the notification letter, customers will receive the following: -Software version Apex 12.6.2, 2.3.2, or 2.4.2 -Instructions to upgrade their systems with the provided software and to verify the new version on the system as a confirmation that the software was successfully loaded. -New Operator's Manual for installations where the operating characteristics of the system have changed due to the software upgrade. For Customers with systems with software versions other than 12.6, 2.3, or 2.4: Customers were asked to upgrade their QDR software, return their old QDR software disk, and complete and return to Hologic the enclosed Confirmation of Notification.
Quantity in Commerce1914 units total
DistributionWorldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Hong Kong, Indonesia, India, Iran, Iraq, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Malaysia, Morocco, Mexico, Pakistan, Peru, Puerto Rico, South Africa, Saudia Arabia, Singapore, Syria, Taiwan, Thailand, Tunisia, Venezuela, and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KGI
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