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Sensica UO System
C. R. Bard, Inc. · Model SSPK1025 · UDI-DI 00801741215643
EXS
Prescription
0
510(k) clearances
464
Adverse events
6
Recalls
8
Facilities
Description
Sensica UO System Ring - ICU
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 during a patient monitor |
| 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 temperature measurement fluc |
| 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 output measurement ina |
| 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 container. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.