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U.S. Department of Health and Human Services

Class 2 Device Recall ProudP

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  Class 2 Device Recall ProudP see related information
Date Initiated by Firm April 21, 2022
Create Date June 27, 2022
Recall Status1 Terminated 3 on September 29, 2023
Recall Number Z-1292-2022
Recall Event ID 90165
Product Classification Uroflowmeter - Product Code EXY
Product ProudP Everyday Uroflow Tracker
Software Version 1.x.x

Software Version 1.2.0 or earlier
Code Information prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
Recalling Firm/
Manufacturer		 Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Seocho-Daero, Seocho
# 413 398 Platinum Tower
Seoul Korea (the Republic of)
For Additional Information Contact Ahnyoung Lee
858-353-1946
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Software design
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 gayeong.kim@soundable.health. Do not use the product if you cannot update the product. For any questions - contact the Regulatory and Quality Assurance Manager at gayeong.kim@soundable.health
Quantity in Commerce 41 devices (out of 1,260 users)
Distribution Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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