Recall Z-1173-2010 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Medical Systems Inc
Xario; SSA-660A; software version 1.0 and later
| Date | Mar 19, 2010 (initiated Nov 12, 2007) |
| Status | Terminated |
| Reason | Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements. |
| Root cause | Component design/selection |
| Action | Toshiba America Medical Systems (TAMS) has issued a Field Modification Instruction notification to all of its customers about the affected devices. The correct software will be administered through TAMS' representatives. Reimbursement for the modification will be given upon receipt of the reimbursement claim invoice. |
| Quantity | 98 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050380 | XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A Toshiba America Medical Systems, In.C, Feb 23, 2005 |