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U.S. Department of Health and Human Services

Class 2 Device Recall Gemini 16 PET/CT sytem, Slice Configuration

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  Class 2 Device Recall Gemini 16 PET/CT sytem, Slice Configuration see related information
Date Initiated by Firm March 11, 2005
Date Posted August 30, 2005
Recall Status1 Terminated 3 on March 02, 2012
Recall Number Z-1418-05
Recall Event ID 32334
510(K)Number K032036  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Gemini 16 PET/CT sytem, Slice Configuration
Code Information All codes.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact George 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
Action The firm sent recall/field correction letters dated 3/11/05.
Distribution The 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 Cycle TPLC 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) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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