Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Recall 90165
Description: ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Recall 90165 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1292-2022 |
| Event ID | 90165 |
| Event Description | ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store. |
| Quantity | 41 devices (out of 1,260 users) |
| Recall 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. |
| Device Classification | 20220706 |
| Device Code Info | prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x |
| Center Classification Date | 20220627 |
| Recall Initiation Date | 20220421 |
| Recalling Firm | Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) |
| Initial Notification | Letter |
| Similar To |