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Philips Medical Systems (Cleveland) Inc recalls GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomo
Recalled November 11, 2015 · FDA recall Z-0197-2016 · Philips Medical Systems (Cleveland)
Hazard
The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure. · FDA Class II
Units
264 units
Sold at
Worldwide Distribution - US Distribution to the states of : AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Canada, Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Luxembourg, Mexico, Netherlands, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and UK.
Description
The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
Product
GEMINI PET/CT System, 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 →