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U.S. Department of Health and Human Services

Class 2 Device Recall GEMINI GXL PET/CT system

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 Class 2 Recall
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Date Posted January 31, 2008
Recall Status1 Open
Recall Number Z-0462-2008
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 GXL 6, 10, & 16 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 GXL Product Numbers/Manufacturer Numbers: GXL 16 slice: 4535 679 71891, GXL 10 slice: 4535 679 75681, GXL 6 slice: 4535 679 75691. Catalog Numbers: GXL 16 slice: 882410, GXL 10 slice: 882400, GXL 6 slice: 882390. Serial Numbers: 4034-4159.
Recalling Firm/
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 126
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.