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FDA (Device enforcement)Recalled 2022-04-21closedclass ii

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

Is my product affected?

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

  • UPC 00860006184902

Check against the official notice below — it lists the full affected range.

What happened

Dain Technology, Inc., a subsidiary of Soundable Health, Inc., has issued a recall for ProudP Everyday Uroflow Tracker software version 1.2.0 and earlier. The software can interfere with the Live Listen feature of hearing aids or AirPods, causing an iPhone to automatically process urination sound signals. This interference results in lower urination volume and velocity readings than the user would actually experience. The software has been distributed worldwide via the Apple App Store, with 41 devices affected out of 1,260 total users.

The recall notice does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store. Quantity: 41 devices (out of 1,260 users) Lot/code info: prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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