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.
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
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.
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.
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.
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.
Verify the software version on your device; affected units have version 1.3.3.42 or earlier.
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.
Check the software version; if it is 1.3.3.42 or earlier, contact ICU Medical for details on the remedy.
The software issue could cause patient identification information to be lost, potentially leading to incorrect patient care. However, the recall does not specify a risk of serious injury.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1927-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1927-2020 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
