ICU Medical Cogent Hemodynamic Monitor Software Issues May Cause Inaccurate Data
ICU Medical recalls Cogent Hemodynamic Monitoring System with software issues that may cause inaccurate readings, unit shutdowns, or loss of secondary parameter display. Affected units include specific serial numbers and software versions.
Lower-risk 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.
Contact the company
What happened, in plain English
ICU Medical is recalling its Cogent Hemodynamic Monitoring System due to software issues that could lead to inaccurate monitoring data, unit shutdowns, or loss of secondary parameter displays. This affects healthcare providers using the system for patient monitoring. Read more at govinfonow.com/recall/67433-icu-medical-cogent-hemodynamic-monitor-software-issues-may-cause-inaccurate.
Source Summary by GovInfoNow · govinfonow.com/recall/67433-icu-medical-cogent-hemodynamic-monitor-software-issues-may-cause-inaccurate · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1835-2020
Cite this page
“ICU Medical Cogent Hemodynamic Monitor Software Issues May Cause Inaccurate Data.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67433-icu-medical-cogent-hemodynamic-monitor-software-issues-may-cause-inaccurate. Based on FDA recall #Z-1835-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1835-2020%22&limit=1).
Why it’s dangerous
The software issues identified by ICU Medical could result in inaccurate patient monitoring data, causing the system to shut down unexpectedly or stop displaying a secondary parameter. This might lead to incorrect patient assessments if the system is used for critical monitoring.
Who’s affected
Healthcare providers using the ICU Medical Cogent Hemodynamic Monitoring System with specific serial numbers and software versions are affected. Patients monitored by this system may be at risk if the software issues cause inaccurate readings.
How to tell if you have this one
Check for the Cogent Hemodynamic Monitoring System with serial numbers listed in the recall notice. Affected units have specific software versions 1.3.2.460 and earlier, and include the Cogent Item Number 58400-000.
- Brand
ICU Medical- Product
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499- Category
Medical device
What to do — step by step
Check Software Version
Verify the software version on your device; affected units have version 1.3.2.460 or earlier.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
FDA distribution: “US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Maryland, Nebraska, New York, North Carolina, Vermont, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1835-2020 (July 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1835-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.