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Philips Medical Systems (Cleveland) Inc recalls Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner
Recalled October 1, 2014 · FDA recall Z-2709-2014 · Philips Medical Systems (Cleveland)
Hazard
The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle. · FDA Class II
Units
364
Sold at
Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India, Taiwan, Australia, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil.
Description
The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.
Product
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →