Oridion Capnostream20 Bedside Patient Monitor Recall for Settings Reset
Oridion Medical is recalling 56 Capnostream20 bedside patient 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 injuries or illnesses have been reported, and the hazard is a functional settings reset rather than a direct physical injury risk, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 56 units of the Capnostream20 (INTL) M bedside patient monitor, model CS08654. 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, Canada, Germany, Japan, and the United Kingdom. The recall covers specific serial codes listed in the agency documentation.
Consumers and healthcare facilities should contact Oridion Medical 1987 Ltd. for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Capnostream20 (INTL) M, CS08654
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 56
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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