Aplio 500/400/300 Diagnostic Ultrasound System recall
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Why was Aplio 500/400/300 Diagnostic Ultrasound System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item numbers: TUS-A300/Wl and TUS-A500/Wl
- Product
- Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 233 units
- Distribution
- Nationwide Distribution.
- Recall date
- April 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)