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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT XRay System

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 Class 2 Device Recall Brilliance CT XRay Systemsee related information
Date Initiated by FirmSeptember 22, 2011
Date PostedDecember 01, 2011
Recall Status1 Terminated 3 on February 22, 2013
Recall NumberZ-0335-2012
Recall Event ID 60228
510(K)NumberK033326 
Product Classification System, X-ray, Tomography, computed - Product Code JAK
ProductBrilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software.
Code Information Model Number: 728231, Serial Numbers: 9745, 90169, and 95414
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information ContactJoseph Vinhais
440-483-7000
Manufacturer Reason
for Recall		Software errors. A number of non-conformances were found for the Brilliance Big Bore and Brilliance 64 Computed Tomography X-ray Systems equipped with software version; 3.5 Beta1. The non-conformances stem from software errors identified in the operating software.
FDA Determined
Cause 2		Software design
ActionPhilips Healthcare released a 'Field Change Order' (FCO #72800531) on September 12, 2011. Philips sent an - URGENT Medical Device Correction letter dated October 17, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to this situation. The letter informed customers on how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Release Notes which were provided to each customer location once the software update is installed. The letter notified the customer that a Philips representative would be installing a software upgrade in order to address the referenced software issues free-of-charge, through a Field Change Order. Customers were instructed to contact their Philips representative or local Philips Healthcare Office for further information or support for this issue. For North America and Canada customers were instructed to contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).
Quantity in Commercethree (3) units were distributed.
DistributionWorldwide Distribution - USA including Texas and the countries of Italy, India and China.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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