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Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Recall 90165

Description: ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Recall 90165 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1292-2022
Event ID90165
Event DescriptionProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Product TypeDevices
DistributionWorldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
Quantity41 devices (out of 1,260 users)
Recall ReasonDue 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.
Device Classification20220706
Device Code InfoprouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
Center Classification Date20220627
Recall Initiation Date20220421
Recalling FirmDain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Initial Notification Letter
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