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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64 and Ingenuity CT

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  Class 2 Device Recall Brilliance 64 and Ingenuity CT see related information
Date Initiated by Firm February 17, 2012
Date Posted March 23, 2012
Recall Status1 Terminated 3 on February 22, 2013
Recall Number Z-1285-2012
Recall Event ID 61363
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance 64 M/N 728231, Ingenuity CT M/N 728326, Dist. By Philips Medical Systems, Cleveland, OH
Code Information System Code # 728231, Serial # 91003, 95130, 95157, 95504 & 300030; System Code # 728326, Serial # 300010 & 300018.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact Joseph Vinhais
440-483-7000
Manufacturer Reason
for Recall		 A number of non-conformances were identified during internal and external validation testing of the Brilliance 64 and Ingenuity CT systems with software version Beta 3 (version 4.0.0.xx368).
FDA Determined
Cause 2		 Software change control
Action Philips Healthcare sent an Urgent Medical Device Correction letter dated February 17, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of the contents in the communication. Customers were asked to retain a copy of the communication with the equipment instruction for Use. For further information or support concerning this issue, customers should contact their local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 440-483-7000.
Quantity in Commerce 7 units
Distribution Worldwide Distribution - USA including OH and the following countries: Australia, China, Belgium, Israel & Sweden.
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 = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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