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Philips Medical Systems (Cleveland) Inc recalls GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for
Recalled July 16, 2014 · FDA recall Z-2037-2014 · Philips Medical Systems (Cleveland)
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. · FDA Class II
Units
33
Sold at
Distributed in the states of CA, CO, IL, OK, OR and WI.
Description
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.
Product
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.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →