FDA-Device2017-07-19Class II

XARIO 200 TUS-X200 diagnostic ultrasound system

Toshiba American Medical Systems Inc
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.

Sold states
Nationwide Distribution
Affected count
1 unit
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
XARIO 200 TUS-X200 diagnostic ultrasound system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2709-2017

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