FDA-Device2021-01-20Class II
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.
ICU Medical, Inc.
Hazard
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
Sold states
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
Affected count
220 units
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0859-2021Don't want to check this manually?
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