Recall Z-1257-2011 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner
| Date | Feb 15, 2011 (initiated Sep 7, 2010) |
| Status | Terminated |
| Reason | Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam Plan. |
| Root cause | Software design |
| Action | Toshiba America Medical Systems (TAMS) issued notification to consignees 9/7/2010, via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification. |
| Quantity | 44 units distributed between 09/2007 - 07/2010 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083282 | MODEL TSX-301B AQUILION CT SYSTEM Toshiba America Medical Systems, In.C, Dec 12, 2008 |