Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
This recall has been terminated (originally issued April 12, 2013).
- Recall Initiated
- December 11, 2012
- Posted
- April 12, 2013
- Terminated
- April 10, 2014
- Recall Number
- Z-1104-2013
- Quantity
- 233 units
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Item numbers: TUS-A300/Wl and TUS-A500/Wl
Root Cause
Device Design
Action Taken
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.