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Philips Medical Systems (Cleveland) Inc recalls Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional imag
Recalled November 4, 2015 · FDA recall Z-0177-2016 · Philips Medical Systems (Cleveland)
Hazard
The firm discovered Ring/Dot artifact due to X-ray measurement error. · FDA Class II
Units
268 units total
Sold at
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.
Description
The firm discovered Ring/Dot artifact due to X-ray measurement error.
Product
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →