FDA recall Z-0859-2021

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.

Reason for recall

Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-11-09

Report date

2021-01-20

Termination date

2023-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0859-2021