FDA-Device2014-07-16Class II
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Philips Medical Systems (Cleveland) Inc
Hazard
When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occurs randomly.
Sold states
Distributed in the states of CA, CO, IL, OK, OR and WI.
Affected count
33
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2037-2014Don't want to check this manually?
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