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ICU Medical, Inc. recalls ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Recalled May 6, 2020 · FDA recall Z-1835-2020 · ICU Medical
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. · FDA Class II
Units
83 units
Sold at
US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None
Description
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.
Product
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →