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Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) recalls ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Recalled July 6, 2022 · FDA recall Z-1292-2022 · Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
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. · FDA Class II
Units
41 devices (out of 1,260 users)
Sold at
Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
Description
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.
Product
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Manufacturer(s)
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →