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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64 and Ingenuity Computed Tomography (CT)

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 Class 2 Recall
Brilliance 64 and Ingenuity Computed Tomography (CT)
see related information
Date Posted January 15, 2013
Recall Status1 Terminated on June 18, 2013
Recall Number Z-0674-2013
Recall Event ID 63817
Premarket Notification
510(K) Number
K033326 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code Information Brilliance CT X-RAY System - Model/System Code #728231, Serial Number distributed in the U.S. was: 9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were: 300018, and 300003. The remaining Serial Numbers distributed overseas were: 91003, 95130, 95157, 95504, and Serial Numbers: 300010, and 300030 .
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Michael McAndrew
800-722-9377
Manufacturer Reason
for Recall
Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, Philips Healthcare, sent an 'URGENT- Medical Device Correction" letters' dated November 15, 2012, and December 3, 2012, to their customers. Both letters describe the product, problem and actions to be taken. The letters state that Philips is notifying all affected customers of this information via a 'Field Safety Notice and will be installing a software update on the affected Brilliance 64 and Ingenuity CT system in order to address these issues. A Philips' Field Service Engineer will be contacting each customer site and make arrangements to install the necessary software update on these device systems. The customers should contact their local Philips representative or local Philips Healthcare office. In North America and Canada needing further information or support concerning this update, should contact our Customer Care Solutions Center at 1-800-722-9377. Selection option 5, and enter their site ID or follow the prompts.
Quantity in Commerce A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas)
Distribution Worldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and 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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