Oridion Capnostream 20P Patient Monitors Recalled for Settings Reset
Oridion Medical is recalling 2,806 Capnostream 20P 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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 2,806 units of the CAPNOSTREAM 20P (US) N W/PRINTER - ROHS bedside patient monitors (Part Number CS08657-02). 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. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities should contact Oridion Medical for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the violation could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 2,806
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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