Medical device recalls Moderate risk

Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) recalls ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

Recall date
April 21, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1292-2022
FDA classification
Class II
Brand / firm
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Sold / distributed
Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.

Why it was recalled

Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination volume and velocity values than expected.

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

What was recalled

ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

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