Oridion CapnoStream 20P Patient Monitor Recall for Settings Reset
Oridion Medical is recalling 16 CapnoStream 20P 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, and the hazard involves a functional defect (settings reset) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 16 units of the CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV 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 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. The specific serial numbers for the affected units are ME30160001 through ME30160016.
Healthcare facilities and users should contact Oridion Medical 1987 Ltd. for instructions on how to resolve the issue. The source text does not specify a particular action such as repair or replacement, but users should verify their device serial numbers against the provided list and contact the manufacturer.
The recalled product
- Product
- CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 16
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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