Oridion Capnostream20 Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling five 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, and the hazard involves settings resetting to factory defaults without reported injuries or deaths, fitting the criteria for a moderate severity issue.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling five units of the Capnostream20 (INTL) N REFURBISHED bedside patient monitors (model CS78652). The recall involves specific serial numbers: B200001309, B200001965, B200001922, B200001084, and B200001075.
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. This could result in incorrect time displays or altered alarm configurations.
The affected products were distributed in the United States, Puerto Rico, and numerous foreign countries including Argentina, Australia, Austria, Bahrain, Belgium, Canada, and others. Users should contact Oridion Medical for further instructions regarding the recall.
The recalled product
- Product
- Capnostream20 (INTL) N REFURBISHED, CS78652
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- B200001309 B200001965 B200001922 B200001084 B200001075
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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