Oridion Capnostream20 Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling eight 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 a functional defect (settings reset) that could compromise monitoring reliability, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling eight units of the Capnostream20 (INTL) M W/PRINTER REFURBISHED (model CS78660) bedside patient monitors. 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.
The affected products were distributed in the United States nationwide and Puerto Rico, as well as to numerous foreign countries including Argentina, Australia, Canada, Germany, Japan, and the UK. The specific serial numbers for the affected units are B300001456, B300001184, B500002163, B500002232, B300001007, B300001120, B300001148, and B300001251.
Healthcare facilities and users should check their inventory for these specific serial numbers. If a unit is identified, it should be removed from service and returned to Oridion Medical 1987 Ltd. for evaluation or replacement in accordance with the recall instructions.
The recalled product
- Product
- Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 8
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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