FDA Device recall Z-1835-2020
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
- FDA Device
- Class II
- terminated
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class II recall of ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499 by Icu Medical, citing firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1835-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-12 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Reason
Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.
Identifiers
| code_info | All serial numbers of Cogent HMS, PN 58400-000, PN 58400-000R (User Interface Module (UIM), PN 58403-000 and Patient In…All serial numbers of Cogent HMS, PN 58400-000, PN 58400-000R (User Interface Module (UIM), PN 58403-000 and Patient Interface Module (PIM), PN 58401-000) with Software Versions 1.3.2.460 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-1835-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.