FDA-Device2016-10-12Class II
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Toshiba American Medical Systems Inc
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.
Sold states
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.
Affected count
165
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0049-2017Don't want to check this manually?
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