Oridion Capnostream20 M NICU Monitors Recalled for Settings Reset
Oridion Medical is recalling 262 Capnostream20 M NICU 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. The hazard involves settings resetting to factory defaults, which is a functional defect without reported injuries or hospitalizations, fitting the Moderate criteria for low-risk issues or voluntary precautionary actions.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 262 units of the Capnostream20 M NICU (CPM), model CS08654RN. The recall is due to a defect where the date/time, nurse call, and alarm settings of the bedside patient monitors 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 source text lists specific serial codes for the affected units.
Consumers and healthcare facilities should contact Oridion Medical for instructions on how to address the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Capnostream20 M NICU (CPM), CS08654RN
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 262
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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