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U.S. Department of Health and Human Services

Class 2 Device Recall The Brilliance 64 and Ingenuity CT Computed Tomography Scanners

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 Class 2 Recall
The Brilliance 64 and Ingenuity CT Computed Tomography Scanners
see related information
Date Posted August 17, 2012
Recall Status1 Terminated on February 22, 2013
Recall Number Z-2223-2012
Recall Event ID 62641
Premarket Notification
510(K) Number
K033326 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code Information System Code # 728231, Serial #s: 91003, 95157, 9654, 95130, and 95504 System Code # 728326, Serial #s: 300010, 300030, and 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
1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Healthcare sent an URGENT - Medical Device Correction letter date July 18, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Phillips will be installing a software update version 4.0.0xx516. A Philips Service Engineer will contact the customer for implementation of the software update on the affected systems free of charge. For further information or support concerning this issue, customers may contact their local Philips representatives or Philips Healthcare office. For North America and Canada, they may also contact the Customer Care Solutions Center (1-800-722-9377, option 5) For questions regarding this recall call 440-483-7000.
Quantity in Commerce 8
Distribution Worldwide Distribution - USA including IN and OH, also, the countries of 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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