Oridion Capnostream20 Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling 43 refurbished Capnostream20 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 that could impact patient monitoring but does not involve reported injuries or deaths, fitting the Moderate criteria for low-risk functional issues.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 43 units of the Capnostream20 (US)M REFURBISHED bedside patient monitors, Part Number CS78653. The recall was initiated because the date/time, nurse call, and alarm settings of these 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. Specific unit codes are listed in the recall documentation.
Consumers and healthcare facilities should contact Oridion Medical 1987 Ltd. for instructions on how to resolve the issue. The company is the recalling firm and manufacturer of the affected devices.
The recalled product
- Product
- Capnostream20 (US)M REFURBISHED, Part Number CS78653
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 43
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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