| Class 2 Device Recall Brilliance CT System, Big Bore Configuration. | |
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
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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. |
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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.
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510(K) Database | 510(K)s with Product Code =
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