Recall Z-1292-2022— Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Class II · Terminated
Class II FDA medical device recall by Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.), initiated 2022-04-21, terminated 2023-09-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-04-21
- Terminated
- 2023-09-29
- Firm location
- Seoul, Korea (the Republic of)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.