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Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Recalled October 12, 2016 · FDA recall Z-0046-2017 · Toshiba American Medical Systems
Hazard
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S. · FDA Class II
Units
165
Sold at
US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.
Description
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
Product
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Manufacturer(s)
Toshiba American Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →