Oridion Capnostream20 Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling 500 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 hazard involves a functional defect (settings reset) that poses a risk of harm but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 500 units of the Capnostream20 (US) M W/PRINTER bedside patient monitors, Part Number CS08659. The recall was initiated because the date/time, nurse call, and alarm settings on these devices 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.
Healthcare facilities and users should check their inventory for the affected serial numbers. If a device is found, it should be removed from service and returned to Oridion Medical 1987 Ltd. for repair or replacement in accordance with the recall instructions.
The recalled product
- Product
- Capnostream20 (US) M W/PRINTER, Part Number CS08659
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 500
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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