ICU Medical Cogent Hemodynamic Monitor: Patient ID Not Stored Due to Software Issue
ICU Medical recalls Cogent Hemodynamic Monitoring System with software issues causing patient ID and information not to be stored. Affected units include specific model numbers and software versions.
Lower-risk recall
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Contact the company
What happened, in plain English
ICU Medical is recalling its Cogent Hemodynamic Monitoring System because software issues prevent patient identification and information from being stored. This could lead to incorrect patient care if the system fails to track patient details during monitoring. Read more at govinfonow.com/recall/65834-icu-medical-cogent-hemodynamic-monitor-patient-id-not-stored-due.
Source Summary by GovInfoNow · govinfonow.com/recall/65834-icu-medical-cogent-hemodynamic-monitor-patient-id-not-stored-due · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1927-2020
Cite this page
“ICU Medical Cogent Hemodynamic Monitor: Patient ID Not Stored Due to Software Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65834-icu-medical-cogent-hemodynamic-monitor-patient-id-not-stored-due. Based on FDA recall #Z-1927-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1927-2020%22&limit=1).
Why it’s dangerous
The software issue causes patient identification and critical health information to not be stored in the system. This means that if the system fails, healthcare providers may not have the correct patient data to make safe treatment decisions.
Who’s affected
Critical care patients, trauma patients, and cardiac surgery patients who use the Cogent Hemodynamic Monitoring System with specific model numbers and software versions are affected. Healthcare providers using these units are most at risk.
How to tell if you have this one
Check for model numbers REF58400-000, REF58400-000R, REF58403, or REF58401 with software versions 1.3.3.42 or earlier. The product is used in critical care settings for patients needing continuous cardiac monitoring.
- Brand
ICU Medical- Product
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF- Category
Medical device
What to do — step by step
Check Software Version
Verify the software version on your device; affected units have version 1.3.3.42 or earlier.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 12 states.
FDA distribution: “US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Florida, Illinois, Maryland, Nebraska, New York, North Carolina, Texas, Vermont, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.2 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.
Questions people ask
Is this product safe to use?
The product may not store patient information correctly, which could lead to incorrect patient care. However, the recall indicates it is not a critical safety hazard requiring immediate stop-use.
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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-1927-2020 (February 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1927-2020 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.