Oridion Capnostream20 Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling 22 refurbished 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, but the source text explicitly states no illnesses or injuries are reported and the hazard is a functional defect (settings reset) rather than a direct physical injury risk, fitting the 'voluntary precautionary recalls' or low-risk defect criteria for a Moderate score.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 22 units of the Capnostream20 (US) M W/PRINTER REFURBISHED bedside patient monitors, Part Number CS78659. 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 specific serial numbers for the recalled units are listed in the source data.
Healthcare facilities should contact Oridion Medical for instructions on how to address this issue. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 22
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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