Oridion Medical recalls Capnostream20 bedside monitors that may reset to factory settings when powered off. This could affect alarm and nurse call functions. Affected units have specific part 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 certain Capnostream20 bedside patient monitors that may reset to factory settings when powered off. This could cause alarm and nurse call functions to reset, potentially leading to missed patient alerts. The recall affects specific model numbers listed in the notice.
When the monitor is powered off, the date/time, nurse call, and alarm settings may reset to factory defaults. This could cause the monitor to lose critical patient monitoring information, but it does not pose an immediate safety risk to patients.
Healthcare professionals using the Capnostream20 monitors for patient monitoring are most at risk. The recall applies to specific model numbers sold in the U.S. between 2020 and 2023.
Check for the part numbers listed in the recall: CS78659, B200001278, B300001166, B300001070, and other specific codes. The monitors were sold in the U.S. between 2020 and 2023.
Verify that the date/time, nurse call, and alarm settings are not reset to factory defaults after powering off the monitor.
The affected part numbers are CS78659, B200001278, B300001166, B300001070, B300001092, B300001097, B300001108, B300001172, B300001181, B300001185, B300001205, B300001278, B300001115, B500001885, B500001831, B300001015, B300001118, B500002336, B300001012, B300001132, B300001139, B500001819.
No, the recall does not require stopping use. The issue is a potential reset of settings when powered off, which does not pose an immediate safety risk.
The affected monitors were sold in the U.S. between 2020 and 2023.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0035-2019 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-0035-2019 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.
