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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64 CT system

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 Class 2 Recall
Brilliance 64 CT system
see related information
Date Posted January 17, 2012
Recall Status1 Terminated on February 22, 2013
Recall Number Z-0778-2012
Recall Event ID 59887
Premarket Notification
510(K) Number
K033326 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code Information Model #728231, Serial Numbers: 4003, 9875, and 90135.
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
Software errors. A number of non-conformances were logged in during in-house testing and external validation testing of Brilliance 64, Brilliance Big Bore, and Ingenuity CT systems, equipped with software version 3.5 Beta 2. The non-conformances are due to software errors identified in these device systems.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Philips sent an "URGENT - Medical Device Correction" notification letters to all affected customers via Certified mail on October 19, 2011. The letter describes the referenced software issues; provides instructions to the customers as to what they can do in order to address these issues; and informs the customers of the firm's upcoming software field/correction. The letter states that a Philips representative will be contacting all affected customers to install the necessary software upgrade through a Field Change Order. This will be implemented free of charge. For information or support contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solution Center 1-800-722-9377, option 5.
Quantity in Commerce 3 units
Distribution Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.
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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