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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT Systems

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 Class 2 Recall
Brilliance CT Systems
see related information
Date Posted October 31, 2007
Recall Status1 Open
Recall Number Z-0110-2008
Recall Event ID 38264
Premarket Notification
510(K) Number
K033326 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Brilliance CT Systems, 40 slice configuration. Computed tomography scanner.
Code Information Model No. 728231. Version 2.2.1
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Manufacturer Reason
for Recall
Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.
FDA Determined
Cause 2
DESIGN: Software Design
Action Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.
Quantity in Commerce 404
Distribution Worldwide, including USA, Canada, Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Denmark, Ecuador, Egypt, England, Equatorial Guinea, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Korea, Lebanon, Libya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Phillipines, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uzbekistan, Venezuela, and West Indies.
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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