Oridion Medical recalls certain Capnostream20 N CYVITAL bedside monitors that may reset to factory settings when powered off. Affected units include specific model numbers listed in the recall notice.
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 specific models of Capnostream20 N CYVITAL bedside patient monitors. The monitors may reset to factory default settings when powered off, which could lead to incorrect alarm or nurse call settings being applied during patient monitoring.
When the monitor is powered off, the date/time, nurse call, and alarm settings may reset to factory defaults. This could cause incorrect settings to be applied when the monitor is turned back on, potentially affecting patient safety.
Healthcare professionals using the Capnostream20 N CYVITAL monitors for patient monitoring are most likely affected. Patients using these monitors could be at risk if settings reset incorrectly.
Check for model numbers listed in the recall notice: B400002614 through B419135329. These units were sold with the specific serial numbers provided in the recall.
Verify that the date/time, nurse call, and alarm settings are not reset to factory defaults after powering off the monitor.
The affected model numbers are B400002614 through B419135329 as listed in the recall notice.
The monitors may reset to factory default settings when powered off, which could lead to incorrect alarm or nurse call settings being applied during patient monitoring.
No, the recall does not require stopping use. However, users should check settings after powering off the monitor to ensure they are correct.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0050-2019 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-0050-2019 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.
