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U.S. Department of Health and Human Services

Class 2 Device Recall GEMINI TF PET/CT system

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 Class 2 Recall
GEMINI TF PET/CT system
see related information
Date Posted January 31, 2008
Recall Status1 Open
Recall Number Z-0461-2008
Recall Event ID 44934
Premarket Notification
510(K) Numbers
K051170  K052460 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems, Philips Medical Systems, Cleveland, OH 44143
Code Information Gemini TF Product Numbers/Manufacturer Numbers: TF 64 slice: 4535 679 94741, TF 16 slice: 4535 679 83931. Catalog Numbers: TF 64 slice: 882471, TF 16 slice: 882470. Serial Numbers: 7001-7058, 7062, 7064, and 7066.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Manufacturer Reason
for Recall
Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Medical notified domestic customers via Product Safety Notification dated May 30, 2007. The product safety notification includes a Technical Bulletin notifying customers of the issue and how to avoid it. This information will be used until the software correction becomes available. The software correction will be released in October 2008. Once software is available, the firm will begin correcting the field.
Quantity in Commerce 61
Distribution Worldwide Distribution - USA, Australia, Belgium, Canada, China, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Korea, Netherlands, Poland, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Taiwan, Turkey, and Venezuela.
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 = RAMSOFT, INC.
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