Z-0047-2017 Class II Terminated
FDA device recall Z-0047-2017 was initiated by Toshiba American Medical Systems Inc on Apr 25, 2016 and is designated Class II. Reason for recall: 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 syste… The recall status is terminated (terminated Jul 13, 2017). Affected quantity: 165.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 12, 2016
- Initiation Date
- Apr 25, 2016
- Termination Date
- Jul 13, 2017
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 165
Product Description
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.
Reason for Recall
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.
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.
Code Information
LL 500