Company: ICU Medical, Inc.
Date of Enforcement Report: 1/20/2021
Class II
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.
Recall Number: Z-0859-2021
REASON
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
RECALLING FIRM/MANUFACTURER
ICU Medical, Inc. on 11/9/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
220 units
DISTRIBUTION
U.S. Nationwide