Recall Z-1169-2010 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Aquilion 64 CT System; Model number TSX-101 A/J The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation
| Date | Mar 19, 2010 (initiated Jan 8, 2009) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large volumes of data are being reconstructed on the secondary console. |
| Root cause | Component design/selection |
| Action | Customer notification was sent and a software upgrade will be issued to all customers affected by the field correction. If you have questions, please call (800) 521-1968. |
| Quantity | 47 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080211 | MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM Toshiba America Medical Systems, In.C, Mar 14, 2008 |