Oridion Capnostream20 N Bedside Monitors Recalled for Settings Reset
Oridion Medical is recalling Capnostream20 N 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, which typically indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The specific defect involves settings resetting, which is a functional issue rather than a direct physical hazard like a fire or shock, placing it in the moderate range.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 20 units of the Capnostream20 N CYVITAL bedside patient monitors (model CS08799). 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. The specific lot codes associated with this recall include B400002614, B400002628, B400002640, B400002642, B400002645, B400002646, B400002653, B400002658, B400002659, B400002660, B400002750, B400002760, B417135110, B417135186, B417135189, B418135223, B418135272, B418135278, B419135324, and B419135329.
Healthcare facilities and users should check their inventory for these specific lot codes. If the devices are found, they should contact Oridion Medical 1987 Ltd. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Capnostream20 N CYVITAL, CS08799
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 20
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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