Home › Device types › EXS
Urinometer, Electrical
FDA product code EXS · Class 2 · Gastroenterology, Urology
17
Registered devices
464
Adverse events
6
Recalls
0
510(k) clearances
Devices with this code
Bard® Uros™ Precision Urine Output and Temperature Monitor — C. R. Bard, Inc.Sensica UO System — C. R. Bard, Inc.Sensica UO System — C. R. Bard, Inc.Bard® Dual Connector to 3.5mm Plug Monitor Cable — C. R. Bard, Inc.Sensica UO System — C. R. Bard, Inc.Sensica UO System — C. R. Bard, Inc.Bard® CritiCore® Face Shield — C. R. Bard, Inc.Sensica UO System — C. R. Bard, Inc.Sensica — ADAPTEC MEDICAL DEVICES LLCSensica UO System — C. R. Bard, Inc.Sensica UO System — C. R. Bard, Inc.Sensica UO System — C. R. Bard, Inc.Bard® CritiCore® Monitor — C. R. Bard, Inc.Sensica UO System — C. R. Bard, Inc.Sensica — C. R. Bard, Inc.Sensica UO System — C. R. Bard, Inc.Sensica UO — ADAPTEC MEDICAL DEVICES LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-15 | C.R. Bard Inc | 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 duri |
| 2022-05-19 | C.R. Bard Inc | Complaints relating to urine output measurement accuracy. |
| 2017-11-10 | C.R. Bard, Inc. | Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms. |
| 2017-11-10 | C.R. Bard, Inc. | BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperat |
| 2017-09-29 | C.R. Bard, Inc. | 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 ou |
| 2010-11-17 | C.R. Bard, Inc., Urological Division | 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 contain |
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