Recall Z-1292-2022 ยท EXY Uroflowmeter
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
| Date | Apr 21, 2022 |
| Status | Terminated |
| 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 pr |
| Quantity | 41 devices (out of 1,260 users) |
| Distribution | Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.