Recall Z-1068-2013 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
| Date | Apr 8, 2013 (initiated Nov 14, 2012) |
| Status | Terminated |
| Reason | Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal. |
| Root cause | Process design |
| Action | Toshiba American Medical Systems Inc. sent a Urgent Medical Device Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer was informed a New software to prevent the occurrence of this issue will be installed on your system. Toshiba Service Representative will contact you for an appointment to install the New Software on your Aquilion One System. Please fax the return reply form to (877) 349-3054. We thank you for your urgent attention to this matter. If you have any fu |
| Quantity | 1 unit |
| Distribution | Distributed in the state of MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122109 | AQUILION ONE VISION, V4.90 Toshiba America Medical Systems, In.C, Sep 21, 2012 |