Z-0049-2017 Class II Terminated
FDA device recall Z-0049-2017 was initiated by Toshiba American Medical Systems Inc on April 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 July 13, 2017). Affected quantity: 165.
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2016
- Initiation Date
- April 25, 2016
- Termination Date
- July 13, 2017
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 165
Product Description
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
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
XL 700