Oridion Medical recalls Capnostream20 M monitors with part number CS08653 and specific serial numbers due to potential reset of date/time and alarm settings when powered off, which could affect patient monitoring accuracy.
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 patient monitors that may reset to factory default settings when powered off. This could cause incorrect date/time and alarm settings, potentially leading to missed patient alerts or inaccurate monitoring.
When the monitor is powered off, the date/time, nurse call, and alarm settings may reset to factory defaults. This could result in incorrect patient monitoring data, such as missed alarms or inaccurate time stamps, but does not cause immediate injury or death.
Healthcare professionals using the Capnostream20 M patient monitors with the specific serial numbers listed in the recall. Patients using these monitors are at low risk if the settings are not reset.
Check if your Capnostream20 M monitor has the part number CS08653 and one of the listed serial numbers (B300001095 through B541123409).
Verify that the date/time and alarm settings are not reset to factory defaults after powering off the monitor.
The part number for the recalled monitors is CS08653.
Check if your Capnostream20 M monitor has the part number CS08653 and one of the listed serial numbers (B300001095 through B541123409).
No, the recall does not require immediate discontinuation of use. However, you should check the settings after powering off the monitor to ensure they are not reset to factory defaults.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0028-2019 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-0028-2019 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.
