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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 Device Recall GEMINI TF PET/CT system see related information
Date Initiated by Firm September 21, 2007
Date Posting Updated January 31, 2008
Recall Status1 Terminated 3 on March 02, 2012
Recall Number Z-0461-2008
Recall Event ID 44934
510(K)Number K052640  K051170  
Product Classification PET/CT Diagnostic Imaging System - 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 OH 44143-2131
For Additional Information Contact
440-483-7000
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
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 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 = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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