Oridion Medical recalls certain Capnostream20 bedside monitors that may reset to factory settings when powered off. Affected units include specific model numbers and serial ranges.
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 bedside monitors because their settings can reset to factory defaults when the device is powered off. This could lead to incorrect patient monitoring readings if the settings are not properly configured after power-off.
When the monitor is powered off, the date/time, nurse call, and alarm settings can reset to factory defaults. This could cause incorrect patient monitoring readings if the settings are not manually adjusted after power-off.
Healthcare professionals using the Capnostream20 bedside monitors for patient monitoring are most at risk. Patients using these monitors may experience inaccurate readings if settings reset.
Check for model numbers B200001046, B400001071, B200001463, B440112961, B200001098, or B200001752 on the device. These are the specific units affected by 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 B200001046, B400001071, B200001463, B440112961, B200001098, and B200001752.
The recall is happening because the monitor settings can reset to factory defaults when powered off, potentially causing incorrect patient monitoring readings.
No, the recall does not require stopping use. Users should check settings after power-off 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-0053-2019 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-0053-2019 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.
