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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT System, Big Bore Configuration.

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  Class 2 Device Recall Brilliance CT System, Big Bore Configuration. see related information
Date Initiated by Firm October 02, 2006
Date Posted March 17, 2007
Recall Status1 Terminated 3 on March 26, 2012
Recall Number Z-0636-2007
Recall Event ID 36685
510(K)Number K033357  
Product Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
Code Information Serial numbers 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact George X. Kambic, Ph.D.
440-483-2557
Manufacturer Reason
for Recall		 Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.
FDA Determined
Cause 2		 Other
Action Customer advisory notification letters dated 10/4/06 and 10/25/06 were sent to consignees providing short term work around instructions. Software modifications installed by the recalling firm will follow as the long term correction.
Quantity in Commerce 17 units
Distribution Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.
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 = and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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