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ICU Medical, Inc. recalls icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of conti
Recalled January 20, 2021 · FDA recall Z-0859-2021 · ICU Medical
Hazard
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration. · FDA Class II
Units
220 units
Sold at
U.S. Nationwide distribution including in the states of AL, AR, CA, CO, FL, IL, KY, MD, ME, MI, NC, NJ, OH, PA, TN, TX, VT, WA and WI. O.U.S.: None
Description
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
Product
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →