FDA-Device2015-11-04Class II
Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Philips Medical Systems (Cleveland) Inc
Hazard
The firm discovered Ring/Dot artifact due to X-ray measurement error.
Sold states
Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
Affected count
108 units
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0174-2016Don't want to check this manually?
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