ProudP Everyday Uroflow Tracker recallZ-1292-2022 · Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) · initiated Apr 21, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
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 [email protected]. Do not use the product if you cannot update the product. For any questions - contact the Regulatory and Quality Assurance Manager at [email protected]
Recall details
- Recall number
- Z-1292-2022
- Status
- Terminated
- Initiated by the company
- Apr 21, 2022
- Recalling firm
- Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
- Quantity
- 41 devices (out of 1,260 users)
- Product code
- EXY
- Distribution
- Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
Product description
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Code information (models, lots, serial numbers)
prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- proudP SU-UFM-001Soundable Health, Inc. · Uroflowmeter1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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