FDAFDA · Food and drugs·Recall number Z-1292-2022
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Published July 6, 2022 · Recall initiated: April 21, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
- Distributor
- Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
- Lot
- prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Korea (the Republic of)
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