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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT

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 Class 2 Recall
Brilliance CT
see related information
Date Posted September 26, 2007
Recall Status1 Terminated on October 05, 2010
Recall Number Z-0014-2007
Recall Event ID 37567
Premarket Notification
510(K) Numbers
K010817  K033326  K033357  K041955  K042935 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.
Code Information Serial #s 30035; 40022; 5059, 50027, 50017; 6011, 6095, 6118, 60006; 9145, 9036, 9115, 9089, 9042, 90061, 90109, 90072, 90050, 90150; 7022.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
For Additional Information Contact George X. Kambic
440-483-2557
Manufacturer Reason
for Recall
A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.
FDA Determined
Cause 2
DESIGN: Software Design
Action The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.
Quantity in Commerce 20
Distribution Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.
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 = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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