BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1292-2022 · Initiated April 21, 2022

    Recall

    Recall Number
    Z-1292-2022
    Event Number
    90165
    Firm
    Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of)
    FEI Number
    3016096130
    Product Code
    EXY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 21, 2022
    Terminated
    September 29, 2023

    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.

    Action

    On 04/21/2022, Soundable Health/ReedSmith LLP (Dain Technology, Inc.) emailed a Customer Notification informing customers that the firm has implemented a mobile application correction to the proudP application due to an issue regarding use of proudP mobile application with the iPhone Listen Live feature or hearing aids which could result in interference with the data collected by the proudP application and provide inaccurate readings. Customer are being informed that an update /correction to the application through the Apple App Store was released on April 21, 2022. If you downloaded your proudP before April 21, 2022, and have not updated the application since then, you will not be able to use proudP after April 21, 2022. Do not use any external devices or features (e.g., hearing aids, Listen Live feature) that activates your iPhone s audioprocessing function when collecting data with proudP. If for any reason you are not able to update the product, please email us at [email protected]. Do not use the product if you cannot update the product. For any questions - contact the Regulatory and Quality Assurance Manager at [email protected]

    Distribution

    Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.

    Quantity

    41 devices (out of 1,260 users)