Medical device recalls Moderate risk

SonarMed Inc recalls SonarMed AirWave Monitor, Model Number M0001

Recall date
April 17, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2450-2019
FDA classification
Class II
Brand / firm
SonarMed Inc
Sold / distributed
CA & TX

Why it was recalled

Potential for the presence of two error codes which would make the monitor inoperable.

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

What was recalled

SonarMed AirWave Monitor, Model Number M0001

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