ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Summary
The FDA issued a Class II for ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2. by Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.). 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 .
Details
Source
Device Recall
External ID
Z-1292-2022
Action Date
2022-07-06
Status
Terminated
Category
device
Product Description
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Lot/Code Info: prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
Quantity Affected: 41 devices (out of 1,260 users)
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.
Distribution
Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-21
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) have FDA actions?
This is the only FDA action we have on record for Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1292-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29