FDA-Device2023-12-20Class II
Sensica Urine Output System, Catalog Number SCCS1002
C.R. Bard Inc
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.
Sold states
US Nationwide distribution.
Affected count
148 units
Manufactured in
8195 Industrial Blvd Ne, N/A, Covington, GA, United States
Products
Sensica Urine Output System, Catalog Number SCCS1002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0554-2024Don't want to check this manually?
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