Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Brillance CT System, 16, 10 and 6 configurations (air cooled version)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Brillance CT System, 16, 10 and 6 configurations (air cooled version)see related information
Date Initiated by FirmMarch 11, 2005
Date PostedAugust 30, 2005
Recall Status1 Terminated 3 on March 02, 2012
Recall NumberZ-1412-05
Recall Event ID 32334
510(K)NumberK010817 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
ProductBrillance CT System, 16, 10 and 6 configurations (air cooled version) using version 1.2 or 1.2.1software.
Code Information All codes.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information ContactGeorge X. Kambic, Ph.D.
440-483-2557
Manufacturer Reason
for Recall		When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
FDA Determined
Cause 2		Other
ActionThe firm sent recall/field correction letters dated 3/11/05.
DistributionThe devices were distributed to consignees throughout the United States and to consigness located in Argentina, Austria, Bahama, Belarus, Belguim, Brazil, Canada, China, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, England, Finland, France, Greece, Germany, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Libya, Mexico, Morocco, Netherlands, New South Wales, New Zealand, Norway, Panama, Phillipines, Portugal, Poland, Romania, Russia, South Africa, Singapore, Slovenia, Spain, Sri Lanka, Switzerland, Sweden, Taiwan, Thailand, Turkey and Venezuela.
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
-
-