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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 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
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
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
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 = JAX and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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