Accuryn SmartFoley Tray System Foley Adapter
POTRERO MEDICAL, INC. · Model FGS-06-UOT.SMCS · UDI-DI 00850019755176
Description
The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn SmartFoley is a single use device intended for short-term use (less than 30 days).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-29 | Emano Metrics, Inc. | Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validat |
| 2022-04-21 | Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) | 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 uri |
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