Reported Apr 24, 2013 · Terminated
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound…
Toshiba American Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toshiba American Medical Systems Inc · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300)
- Device Listing NumberDl53118. Diagnostic Ultrasound system
- Lot codes and dates
- Item numbersTUS-A300/Wl and TUS-A500/Wl
- Amount recalled
- 233 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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