ICU Medical recalls Cogent Hemodynamic Monitoring System due to potential software issue causing incorrect continuous cardiac output readings after PulseCO calibration. Affected units may display wrong cardiac output values.
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
ICU Medical is recalling its Cogent Hemodynamic Monitoring System because a software issue might cause it to show incorrect continuous cardiac output (CCO) values after PulseCO calibration. This could lead to inaccurate patient monitoring during critical care.
The software issue can cause the device to display incorrect continuous cardiac output values after PulseCO calibration. This might lead to improper patient treatment decisions if healthcare providers rely on the inaccurate readings.
Healthcare providers using the Cogent system for patient cardiac monitoring. Patients receiving critical care monitoring with this device may be at risk of inaccurate readings.
The Cogent Hemodynamic Monitoring System with serial numbers listed in the recall notice. The product was sold with specific list numbers and item codes.
Look for the serial number on your device, which should match one of the listed numbers in the recall notice.
The recall is due to a potential software issue that may cause the device to show incorrect continuous cardiac output values after PulseCO calibration.
Check your device's serial number against the list of numbers provided in the recall notice.
The recall notice 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-0859-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0859-2021 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.
