Oridion Medical recalls Capnostream20 bedside monitors that may reset to factory settings when powered off. This could affect patient monitoring accuracy. Affected units have specific serial numbers listed in the recall.
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 Capnostream20 bedside patient monitors that may reset to factory default settings when powered off. This could lead to inaccurate patient monitoring readings if the monitor is not properly configured after power cycles.
When the monitor is powered off, the date/time, nurse call, and alarm settings may reset to factory defaults. This could cause incorrect patient monitoring readings if the settings are not manually adjusted after power cycles. However, the reset is a software issue that does not typically cause physical harm.
Healthcare professionals using Capnostream20 bedside monitors in hospitals or clinics. Patients using these monitors are at low risk as the reset is unlikely to cause immediate harm.
Check for the model name 'Capnostream20 (INTL) M W/PRINTER' and serial numbers listed in the recall (e.g., B300001031, B300001047). The product was sold internationally starting from the date specified in the recall notice.
After powering on the monitor, verify that the date/time, nurse call, and alarm settings are not reset to factory defaults.
No, the recall does not require stopping use. The issue is a software reset that can be checked and corrected by verifying settings after power cycles.
The affected units have specific serial numbers listed in the recall, including B300001031, B300001047, B300001049, and others as provided in the recall notice.
The recall does not mention a specific fix. Users should check the monitor settings after power cycles 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-0047-2019 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-0047-2019 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.
