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U.S. Department of Health and Human Services

Class 2 Device Recall Brillance CT System

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 Class 2 Device Recall Brillance CT Systemsee related information
Date Initiated by FirmDecember 27, 2005
Date PostedSeptember 26, 2014
Recall Status1 Terminated 3 on November 06, 2015
Recall NumberZ-2709-2014
Recall Event ID 69123
510(K)NumberK010817 K033326 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductBrilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
Code Information 728256, 728251, 728246, 728240, and 728235.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7600
Manufacturer Reason
for Recall		The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.
FDA Determined
Cause 2		Device Design
ActionCustomers will be contacted by a field service technician with the field correction order. The firm will install the new labeling to the device.
Quantity in Commerce364
DistributionWorldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India, Taiwan, Australia, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil.
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
510(K)s with Product Code = JAK
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