Recall Z-2895-2011 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
| Date | Jul 29, 2011 (initiated Jan 7, 2011) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may be broken due to failure of the optical conversion connector, resulting in a break of communication between units. |
| Root cause | Software design |
| Action | Toshiba America Medical Systems, Inc. sent an "Urgent Medical Device Correction" letter dated January 4, 2011 to all affected customers. The letter provides the customers with an explanation of the problem and the firms plan to install preventive measures and provided them with a Customer Reply form to send Toshiba. A representative will contact the customers for an appointment to install the measures to their CT system. For question on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968. |
| Quantity | 6 |
| Distribution | (USA) Nationwide Distribution including the states of WI, MO, TN, IA, AL, AZ, TX, and GA. |
| 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 |