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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