Recall Z-2179-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Medical Systems Inc
Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System
| Date | May 10, 2011 (initiated Apr 20, 2010) |
| Status | Terminated |
| Reason | There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely. |
| Root cause | Device Design |
| Action | The recall was initiated on 4/20/10 with Toshiba America Medical Systems (TAMS) forwarding a Medical Device Correction with a Customer Reply Form (via US Postal Service for US Customers) to all customers who purchased the SSH-880CV Aplio Artida Diagnostic Ultrasound System. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to avoid this problem until corrective action is taken, in case this problem occurs; please contact their Toshiba Representative. If emergency use is necessary, use the following procedure |
| Quantity | 14 |
| Distribution | USA, including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090158 | APLIO ARTIDA V2.0 SSH-880CV Toshiba America Medical Systems, In.C, Feb 6, 2009 |