Oridion Capnostream20 Bedside Patient Monitors Recalled for Settings Reset
Oridion Medical is recalling 769 Capnostream20 bedside 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: This is an FDA Class II recall. The hazard involves a functional defect where settings reset, which is a significant quality issue but does not involve reported injuries, deaths, or immediate life-threatening physical hazards like fire or shock.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 769 units of the Capnostream20 (US) M bedside patient monitor, Part Number CS08653. The recall was initiated because the date/time, nurse call, and alarm settings on these devices 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, Canada, and the United Kingdom. The recall covers specific lot codes listed in the official FDA record.
Healthcare facilities and consumers should check their devices against the provided lot codes. If a device is affected, users should contact Oridion Medical for instructions on how to proceed, as the device may not retain critical alarm and time settings during power cycles.
The recalled product
- Product
- Capnostream20 (US) M, Part Number CS08653
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 769
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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