Oridion Medical recalls Capnostream20 M adult ICU monitors (CS08654RA) due to potential reset of alarm settings when powered off. Affected units may require reconfiguration.
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Oridion Medical is recalling certain Capnostream20 M adult ICU monitors because turning them off can reset alarm and nurse call settings to factory defaults. This could cause missed alarms or patient safety issues if not corrected.
When the monitor is powered off, the alarm settings and nurse call functions may reset to factory defaults. This could lead to missed critical alerts or communication issues with staff during patient monitoring.
Healthcare professionals using the Capnostream20 M adult ICU monitors (model CS08654RA) are most at risk. Patients in critical care settings could face safety issues if alarms reset unexpectedly.
Check for the model number CS08654RA on the monitor. The product was sold with serial numbers B3000011359, B300001366, B300001445, B300001452, and B300001460.
Verify alarm and nurse call settings after powering on the monitor to ensure they are not reset to factory defaults.
No, but you should check settings after powering on to ensure alarms are configured correctly.
The affected model is CS08654RA with serial numbers B3000011359, B300001366, B300001445, B300001452, and B300001460.
The recall does not specify a fix; users must manually check settings after powering on.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0045-2019 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-0045-2019 from Oridion 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.