Recall Z-0859-2021— ICU Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-11-09, terminated 2023-04-19. It names one FDA 510(k) clearance: K152006. 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: Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-09
- Terminated
- 2023-04-19
- Firm location
- San Clemente, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.