Oridion Capnostream20 Bedside Monitors Recalled for Settings Reset Defect
Oridion Medical is recalling 400 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a functional failure (settings reset) that could impact patient monitoring but does not involve reported injuries or immediate life-threatening hazards.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 400 units of the Capnostream20 (US) M W/PRINTER TO MASIMO bedside patient monitors, Part Number CS08751. The recall is due to a defect where the date/time, nurse call, and alarm settings may reset to factory default settings when the monitor is powered off.
The affected products were distributed nationwide in the United States and Puerto Rico, as well as to numerous foreign countries including Argentina, Australia, Austria, Bahrain, Belgium, Canada, and others. The recall covers specific serial numbers listed in the agency's official documentation.
Consumers and healthcare facilities should check their inventory for the affected serial numbers. If a unit is affected, users should contact Oridion Medical for instructions on how to proceed with the recall.
The recalled product
- Product
- Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 400
Distribution
Part of a larger recall action
This product is one of 37 recalled by Oridion Medical 1987 Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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