FDA recall Z-1292-2022

Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) · Class II · device

Product

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

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.

Key facts

Status: Terminated
Initiation date: 2022-04-21
Report date: 2022-07-06
Termination date: 2023-09-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Seoul, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1292-2022