Z-1292-2022Class II

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

Name: Z-1292-2022 ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Creator: Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Published: 2022-04-21
License: https://open.fda.gov/license/

Soundable Health Korea, Inc. (Subsidiary of Soundable Health, Inc.) / initiated 2022-04-21 / Terminated / root cause: software

FDA source

Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) began a recall of ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier on 2022-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1292-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-21
Posted: 2022-06-27
Terminated: 2023-09-29
Recalling firm: Soundable Health Korea, Inc. (Subsidiary of Soundable Health, Inc.)
Product: ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Product code: EXY Uroflowmeter
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.
Root cause tag: software
FDA 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 [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]
Quantity in commerce: 41 devices (out of 1,260 users)
Distribution: Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
Product codes and lots: prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1292-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1292-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-06	2022-06-27

Product code EXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)