Medical device recalls Moderate risk

Withings Sas recalls Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

Recall date
June 11, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2829-2018
FDA classification
Class II
Brand / firm
Withings Sas
Sold / distributed
US Nationwide Distribution

Why it was recalled

Device could not meet the requirements for systolic pressure

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

What was recalled

Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

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