The Cogent Hemodynamic Monitoring System — Class II medical device recall Z-1927-2020
Terminated recall by ICU Medical, Inc., reported 2020-05-13, distributed nationwide. Firm identified software issues which leads to the patient ID and patient information not being stored in the
| Recall number | Z-1927-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2020-02-14 |
| Classified | 2020-05-07 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2023-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 123 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840619079499, 00840619079505, 00840619099459 |
| Model numbers | 58400-000, 58400-000R, 58401, 58403 |
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 for recall
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1927-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.