Recall Z-1104-2013 ยท ITX Transducer, Ultrasonic, Diagnostic
Toshiba American Medical Systems Inc
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
| Date | Apr 12, 2013 (initiated Dec 11, 2012) |
| Status | Terminated |
| Reason | Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system. |
| Root cause | Device Design |
| Action | Toshiba sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated December 11, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (800) 421-1968 for questions regarding this letter. |
| Quantity | 233 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.