FDA Device recall Z-1927-2020
The Cogent Hemodynamic Monitoring System
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of The Cogent Hemodynamic Monitoring System by Icu Medical, citing firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1927-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-14 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - 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. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.
Reason
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Identifiers
| code_info | All serial numbers of Cogent HMS, List Number(s): 58400-000; 58400-000R; 58403-000; 58401-000 with Software Versions 1.3.3.42 and prior are impacted. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1927-2020%22
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