Medical device recalls Moderate risk

Toshiba American Medical Systems Inc recalls APLIO 500 TUS-A500 diagnostic ultrasound system

Recall date
May 1, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2711-2017
FDA classification
Class II
Brand / firm
Toshiba American Medical Systems Inc
Sold / distributed
Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

APLIO 500 TUS-A500 diagnostic ultrasound system

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