Oridion Capnostream20 Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling 46 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect involves settings resetting, which is a functional issue rather than a direct physical hazard like fire or shock, fitting the Moderate category for a device with no reported injuries.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 46 units of the Capnostream20 (US) N REFURBISHED bedside patient monitors, Part Number CS78651. 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. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare facilities and users should contact Oridion Medical 1987 Ltd. for instructions on how to resolve the issue. The company is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Capnostream20 (US) N REFURBISHED, Part Number CS78651
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 46
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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