ProudP Everyday Uroflow Tracker Software Version 1.x.x recall
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Why was ProudP Everyday Uroflow Tracker Software Version 1.x.x 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
- Product
- ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
- Recalling firm
- Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
- Quantity
- 41 devices (out of 1,260 users)
- Distribution
- Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
- Recall date
- July 6, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)