FDAFDA · Food and drugs·Recall number Z-2709-2017
XARIO 200 TUS-X200 diagnostic ultrasound system
Published July 19, 2017 · Recall initiated: May 1, 2017
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
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems Inc
- Distributor
- Nationwide Distribution
- Lot
- Serial Number W5B1712472
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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