Recall Z-3197-2011 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
TSX-201A: AQUlLlON LB; System, X-Ray, Tomography, Computed X-Ray Tomography
| Date | Sep 13, 2011 (initiated Jun 22, 2011) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray, Tomography, Computed, and TSX-1O1A: AQUILION 16; System, X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorr |
| Root cause | Software design |
| Action | Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 22, 2011, to all affected customers. Customers were instructed that a revised software to prevent occurrence of the problem would be installed on their system. Their Toshiba Service Representative would contact them for an appointment to install the software to their system when it became available. Customers were requested to take temporary measures until corrective measures were taken. 1) In dual scanoscopy, do not press the short key between the completion of the first scanoscopy and the st |
| Quantity | 155 units total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050458 | TSX-201A AQUILION LB CT SCANNER Toshiba America Medical Systems, In.C, Mar 10, 2005 |