|
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
|
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.
|
|
|
|