Oridion Capnostream20 Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling 48 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 without reported injuries or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 48 units of the Capnostream20 (US) N W/PRINTER REFURBISHED bedside patient monitors, Part Number CS78657. 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 nationwide in the United States and Puerto Rico, as well as to numerous foreign countries including Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.
Healthcare facilities and users should contact Oridion Medical for instructions on how to address the issue. The specific serial numbers affected are listed in the agency's recall record.
The recalled product
- Product
- Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 48
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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