Device evidence

device-recall:cfres:184611

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 recall number

Z-0859-2021

Evidence summary

Product code: DXG
Recall status: Terminated
Event initiated: November 09, 2020
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0859-2021