FDA-Device2020-05-06Class II
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
ICU Medical, Inc.
Hazard
Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.
Sold states
US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None
Affected count
83 units
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1835-2020Don't want to check this manually?
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