Recall Z-0859-2021 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
ICU Medical, Inc.
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.
| Date | Nov 9, 2020 |
| Status | Terminated |
| Reason | Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration. |
| Root cause | Software design |
| Action | On 11/09/2020, the firm's sent an "URGENT: MEDICAL DEVICE CORRECTION" Notice via traceable mailing informing them that the Recalling Firm has identified a software issue with it Hemodynamic Monitoring System which could potentially display the incorrect continuous cardiac output (COO) values after calibration. The Recalling Firm is informing it customer that if the following calibration steps are taken: Step 1: Start PulseCO monitoring by pressing the CCO button which forces a zeroing of the arterial pressure waveform; press zero on Cogent then reinitiate arterial pressure monitoring. Step 2: |
| Quantity | 220 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152006 | Cogent Hemodynamic Monitoring System Icu Medical, Inc., May 5, 2016 |