ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Reported: July 6, 2022 Initiated: April 21, 2022 #Z-1292-2022
Product Description
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
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.
Details
- Recalling Firm
- Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
- Units Affected
- 41 devices (out of 1,260 users)
- Distribution
- Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
- Location
- Seoul
Frequently Asked Questions
What product was recalled? ▼
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier. Recalled by Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.). Units affected: 41 devices (out of 1,260 users).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2022. Severity: Moderate. Recall number: Z-1292-2022.
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