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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 Recall
Brilliance 64 and Ingenuity CT
see related information
Date Posted March 23, 2012
Recall Status1 Terminated on February 22, 2013
Recall Number Z-1285-2012
Recall Event ID 61363
Premarket Notification
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, Ohio 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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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