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Philips Medical Systems (Cleveland) Inc recalls The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images o
Recalled September 24, 2014 · FDA recall Z-2666-2014 · Philips Medical Systems (Cleveland)
Hazard
Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode. · FDA Class II
Units
257
Sold at
Nationwide Distribution incuding states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, and WI.
Description
Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode.
Product
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →