Seoul, Korea (the Republic of)
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) recalls
1 recall recorded since 2018, most recently on 21 April 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 21 April 2022
- Terminated
- 29 September 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1292-2022
- ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.