Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound
FDA device recall Z-1104-2013 · posted 2013-04-12 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 233 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-12-11
- Date posted
- 2013-04-12
- Date terminated
- 2014-04-10
- Location
- Tustin, CA
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