Z-1292-2022 Class II Terminated
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