Oridion CAPNOSTREAM 20 Patient Monitors Recalled for Settings Reset
Oridion Medical is recalling CAPNOSTREAM 20 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 settings reset that could impact alarm functionality, but no injuries or illnesses are reported in the source text.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling the CAPNOSTREAM 20 (US) N W/PRINTER bedside patient monitors, Part Number CS08657. The recall involves 1,798 units that were distributed nationwide in the United States and Puerto Rico, as well as to numerous foreign countries.
The recall is being issued because the date/time, nurse call, and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. This defect could result in the loss of specific configuration settings upon power cycling.
Healthcare facilities and consumers should contact Oridion Medical 1987 Ltd. for instructions on how to address the issue. The source text does not specify a particular consumer action such as returning the device or stopping use, but users should verify their specific configuration settings and contact the manufacturer for guidance.
The recalled product
- Product
- CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 1,798
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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