Recall Z-1113-2014 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the
| Date | Mar 3, 2014 (initiated Oct 1, 2013) |
| Status | Terminated |
| Reason | Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start. |
| Root cause | Software design |
| Action | Toshiba sent an Urgent Medical Device Correction letter on October 1, 2013, via USPS return receipt mail and accompanied by a response form. The recall notification letter provided the Device Model, serial number, SID, problem, corrective action, request to customers, and contact information (800) 421-1968 or (800) 521-1968. Toshiba designed and test an upgraded ROM for the SC2 PWB to prevent recurrence of the fault. Service technicians will replace the ROM on site at no cost to the system owners. All repairs are expected to be completed by April 2014 and progress reports will be provided |
| Quantity | 338 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |