FDA Enforcement
Class II
Terminated
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Recall: Z-1292-2022
·
Reported July 6, 2022
Enforcement
- Recall Number
- Z-1292-2022
- Event ID
- 90165
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 6, 2022
- Initiation Date
- April 21, 2022
- Classification Date
- June 27, 2022
- Termination Date
- September 29, 2023
- Address
- Seocho-Daero, Seocho, # 413 398 Platinum Tower, Seoul, N/A, Korea (the Republic of)
Description
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
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.
Code Info
prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
Distribution
Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
Quantity
41 devices (out of 1,260 users)