Recall Z-1292-2022
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) · initiated April 21, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Codes / lots: prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
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: Software design
Action taken
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
Details
- Recall number
- Z-1292-2022
- Initiated
- April 21, 2022
- Terminated
- September 29, 2023
- Product code
- EXY – Uroflowmeter
- Quantity
- 41 devices (out of 1,260 users)
- Distribution
- Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
- Recalling firm
- Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)