Recall Z-0049-2017 ยท KPS System, Tomography, Computed, Emission
Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
| Date | Oct 6, 2016 (initiated Apr 25, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Toshiba America Medical System, Inc. planned action to bring the defect into Compliance: 1. A notification will be sent to customers with affected systems in compliance with 21 CFR 1003.21 upon approval by the Secretary. The notification letter includes a statement by the correction will be made at no cost to the customer. 2. To correct this issue, modified software will be installed on the systems to prevent this occurrence from happening. The consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. 3. To avoid thi |
| Quantity | 165 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.