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C.R. Bard Inc recalls Sensica Urine Output System, Catalog Number SCCS1002
Recalled December 20, 2023 · FDA recall Z-0554-2024 · C.R. Bard
Hazard
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. · FDA Class II
Units
148 units
Sold at
US Nationwide distribution.
Description
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.
Product
Sensica Urine Output System, Catalog Number SCCS1002
Manufacturer(s)
C.R. Bard Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →