Devices

GEMINI GXL PET/CT system

Model / Serial
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.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
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.
Product Description
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
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
- Recall of GEMINI GXL PET/CT system

Manufacturer

Philips Medical Systems (Cleveland) Inc

Manufacturer Address
Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
Source
USFDA

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