Z-1292-2022 Class II Terminated
FDA device recall Z-1292-2022 was initiated by Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) on April 21, 2022 and is designated Class II. 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 ve… The recall status is terminated (terminated September 29, 2023). Affected quantity: 41 devices (out of 1,260 users).
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2022
- Initiation Date
- April 21, 2022
- Termination Date
- September 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 devices (out of 1,260 users)
Product Description
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
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.
Distribution Pattern
Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
Code Information
prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x