FDA Medical Device Recalls (openFDA)
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.): ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
- Recall number
- Z-1292-2022
- Recalling firm
- Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
- Product
- ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
- Status
- Terminated
- Initiated
- 2022-04-21
- Posted
- not on file
- Terminated
- 2023-09-29
- 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.
- Root cause
- Software design
- Action
- On 04/21/2022, Soundable Health/ReedSmith LLP (Dain Technology, Inc.) emailed a Customer Notification informing customers that the firm has implemented a mobile application correction to the proudP application due to an issue regarding use of proudP mobile application with the iPhone Listen Live feature or hearing aids which could result in interference with the data collected by the proudP application and provide inaccurate readings. Customer are being informed that an update /correction to the application through the Apple App Store was released on April 21, 2022. If you downloaded your proudP before April 21, 2022, and have not updated the application since then, you will not be able to use proudP after April 21, 2022. Do not use any external devices or features (e.g., hearing aids, Listen Live feature) that activates your iPhone s audioprocessing function when collecting data with proudP. If for any reason you are not able to update the product, please email us at gayeong.kim@soundable.health. Do not use the product if you cannot update the product. For any questions - contact the Regulatory and Quality Assurance Manager at gayeong.kim@soundable.health
- Quantity
- 41 devices (out of 1,260 users)
- Distribution
- Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
- Lot, serial or model codes
- prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EXY
- Firm FEI
- 3016096130
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28