Urinometer, Electrical
Gastroenterology, Urology · 21 CFR 876.1800
Recent MDR events
464 adverse event reports on file
- SENSICA URINE OUTPUT SYSTEMJul 9, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04366
- SENSICA UO SYSTEMFeb 5, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-00656
- SENSICA UO SYSTEMJan 28, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-00435
- SENSICA UO SYSTEMSep 9, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-07722
- SENSICA UO SYSTEMAug 26, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-07049
- SENSICA UO SYSTEMAug 21, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-06929
- SENSICA UO SYSTEMAug 13, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-06741
- SENSICA UO SYSTEMJun 24, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-04890
- SENSICA UO SYSTEMJun 24, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-04949
- SENSICA UO SYSTEMJun 23, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-04814
Event type breakdown
Recalls
6 recall events for this product code
- C.R. Bard IncOpen, ClassifiedDec 14, 2023
Sensica Urine Output System, Catalog Number SCCS1002
BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.
Z-0554-2024 · View FDA record ↗ - C.R. Bard, Inc.TerminatedJan 29, 2018
BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M
The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
Z-0488-2018 · View FDA record ↗ - C.R. Bard, Inc., Urological DivisionTerminatedDec 21, 2010
Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014.
Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container.
Z-0719-2011 · View FDA record ↗ - C.R. Bard, Inc.TerminatedUnknown
BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
Z-0565-2018 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedUnknown
Sensica Urine Output System
Complaints relating to urine output measurement accuracy.
Z-1293-2022 · View FDA record ↗ - C.R. Bard, Inc.Open, ClassifiedUnknown
CritiCore Automated Urine Output and Temperature Monitor
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
Z-2243-2018 · View FDA record ↗
Registered firms
8 firms currently registered for this product code
Philips Electronics Ltd
Mississauga Ontario, CA
C.r. Bard, Inc.
COVINGTON, GA, US
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
C.r. Bard, Inc.
MADISON, GA, US
Bytec Legal Manufacturer Gmbh
Eschweiler North Rhine-Westphalia, DE
Productos Para El Cuidado De La Salud
NOGALES Sonora, MX
Robling Medical, Llc
Youngsville, NC, US
Dymax, Corp.
Zelienople, PA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.