# FDA recall Z-1835-2020

> **ICU Medical, Inc.** · Class II · device recall initiated 2019-07-12.

## Product

ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

## Reason for recall

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.

## Distribution

US Nationwide Distribution in the states of  FL, WI, NY, NC, VT, IL, MD, CA, NE, WA  OUS: None

## Key facts

- **Recall number:** Z-1835-2020
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-12
- **Report date:** 2020-05-06
- **Termination date:** 2023-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Clemente, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1835-2020

## Citation

> AI Analytics. FDA recall Z-1835-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1835-2020. Source: US FDA. Licensed CC0.

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