FDA-Device2014-02-19Class II
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Hazard
The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.
Sold states
Product was shipped to the following states: AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT & WI. Product was also shipped to the following countries: Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia & Venezuela.
Affected count
47 Units
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0979-2014Don't want to check this manually?
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