Recall Z-1665-2011 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.
| Date | Mar 16, 2011 (initiated Jul 22, 2010) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console. |
| Root cause | Software design |
| Action | The firm, Toshiba America Medical Systems (TAMS), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 22, 2010, to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that a new relay will be installed to prevent the occurrence of the problem within the next 90 days and that their Toshiba Service Representative will contact them to install the part to their Aquilion ONE/Premium System. The customers were instructed to contact their Toshiba Service Representative, if the problem occurs before the corrective action has |
| Quantity | 43 units |
| Distribution | Nationwide distribution: USA including states of: AL, AR, AZ, CA, CO, FL, GA, IA, KY, LA, MA, MD, MI, MN, MT, ND, NJ, NV, NY, OH, PA, PR, TX, VA, WI, and WY. |
| 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 |