FDAFDA · Food and drugs·Recall number Z-1104-2013
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Published April 24, 2013 · Recall initiated: December 11, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems Inc
- Distributor
- Nationwide Distribution.
- Lot
- Item numbers: TUS-A300/Wl and TUS-A500/Wl
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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