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Philips Medical Systems (Cleveland) Inc recalls Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 4414
Recalled March 6, 2013 · FDA recall Z-0786-2013 · Philips Medical Systems (Cleveland)
Hazard
The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU). · FDA Class II
Units
1,474 Units
Sold at
Worldwide Distribution - USA ( nationwide) including the states of AK, AL, AR, AZ, CA, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, WA, WV and WY, and the countries of Albania, Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, China, Colombia, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Gibraltar, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Venezuela, Viet Nam & Yemen.
Description
The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
Product
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are 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 →