Oridion Medical CAPNOSTREAM 20P Patient Monitor Recall for Settings Reset
Oridion Medical is recalling 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 hazard involves a functional defect (settings reset) without reported injuries or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling the CAPNOSTREAM 20P (US) N - ROHS bedside patient monitors, Part Number CS08651-02. The recall involves 10,356 units that were distributed nationwide in the United States, Puerto Rico, and 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 issue could result in the loss of specific user-configured settings upon power cycling.
Healthcare facilities and consumers should check their inventory for the affected part number and lot codes listed in the official recall notice. Users should contact Oridion Medical 1987 Ltd. for instructions on how to address the issue or obtain a replacement.
The recalled product
- Product
- CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 10,356
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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