Oridion Medical recalls Capnostream20 M NICU monitors (CS08654RN) that reset alarm settings when powered off. Affected units may require reconfiguration to avoid incorrect patient monitoring.
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 NICU patient monitors because they reset to factory settings when powered off. This could lead to incorrect alarm settings during patient monitoring, potentially causing missed critical alerts.
When the monitor is powered off, the date, time, nurse call, and alarm settings may reset to factory defaults. This could cause incorrect alarm settings to be active when the monitor is powered on again, potentially leading to missed critical patient alerts if the settings were not properly adjusted after a power cycle.
Healthcare providers using the Capnostream20 M NICU monitors, particularly those in neonatal intensive care units. The risk is low as the issue only affects settings when the monitor is powered off, not during normal operation.
Check for the model number CS08654RN on the monitor. Affected units include specific serial numbers listed in the recall notice (e.g., B300001035, B300001077).
Verify that the date, time, nurse call, and alarm settings are correctly configured after powering the monitor on.
No, the recall does not require stopping use. The issue only affects settings when powered off, so normal operation is safe.
Check for the model number CS08654RN and the specific serial numbers listed in the recall notice (e.g., B300001035, B300001077).
Ensure the date, time, nurse call, and alarm settings are correctly configured after powering the monitor 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-0046-2019 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-0046-2019 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.
