Philips Medical Systems (Cleveland) Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Philips Medical Systems (Cleveland) Inc is recalling Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic imaging systems for fi due to 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 m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026