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.
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.
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.
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.
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.
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.
Verify the software version on your device; affected units have version 1.3.2.460 or earlier.
Software versions 1.3.2.460 and earlier are affected.
No immediate stop is required; check the software version to determine if your device is affected.
The recall does not specify a remedy, so contact ICU Medical for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1835-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1835-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
