Recall Z-2542-2016 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Medical Systems Inc
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
| Date | Aug 4, 2016 |
| Status | Terminated |
| Reason | Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction letter was sent to all customers to bring to attention a potential problem of transducer heating with your Xario Ultrasound System. The letter informs the customers that the surface of the acoustic lens of a transducer may become hot because of a software error. The error occurs when a transducer is disconnected, reconnected, or another transducer is selected. The letter informs the customers of error message and the corrective action. Customers are instructed to complete the attached form and fax it to (877) 349-3054 or TAMS-RegulatoryAffairs@toshiba.com. |
| Quantity | 93 units |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |