Device product
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Z-0047-2017
Product summary
- Event
- Event 74871
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165
- Official record key
device-enforcement:Z-0047-2017
Official wording
Reason: 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.
Code information: LL 500
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.