FDA-Device2017-07-19Class II
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 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
28 units
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2712-2017Don't want to check this manually?
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