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Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer re

Recalled August 17, 2016 · FDA recall Z-2366-2016 · Philips Medical Systems (Cleveland)

Hazard
Software defect causing intermittently slow response of Host. · FDA Class II
Units
318 units
Sold at
Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Description

Software defect causing intermittently slow response of Host.

Product
Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer re | RecallWatchUSA