| Class 2 Device Recall Brilliance CT System, Big Bore Configuration | |
Date Initiated by Firm | January 09, 2007 |
Date Posted | September 22, 2014 |
Recall Status1 |
Terminated 3 on November 06, 2015 |
Recall Number | Z-2678-2014 |
Recall Event ID |
69102 |
510(K)Number | K033357 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAX
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Product | No packaging. The device is a computed tomography scanner.
Intended to provide corss sectional images of the human body and visualization of the internal organs of the body. |
Code Information |
Model 728243 Software version 2.2.1 and 2.2.2 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | 440-483-7600 |
Manufacturer Reason for Recall | When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate. |
FDA Determined Cause 2 | Labeling design |
Action | Philips sent a Product Safety Notification letter dated December 21, 2006 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the Product Safety Notification to all affected users and keep a copy of the notification with the Instructions for Use until further notice. Customers with questions were instructed to contact Customer Care Center at 1-800-722-9377, option 5 - Diagnostic Imaging, option 1 - CT.
For questions regarding this recall call 440-483-7600. |
Quantity in Commerce | 61 |
Distribution | Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand. |
Total Product Life Cycle | TPLC Device Report |
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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 = JAX
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