Oridion CapnoStream 20 Bedside Patient Monitor Recall for Settings Reset
Oridion Medical is recalling 245 CapnoStream 20 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) that could impact patient monitoring but does not involve reported injuries or immediate life-threatening mechanical failure.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 245 units of the CAPNOSTREAM 20 (INTL) N bedside patient monitor, Part Number CS08652. The recall was initiated because the date/time, nurse call, and alarm settings on the monitors may reset to factory default settings when the device 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, and others. The recall covers specific lot codes listed in the agency's documentation.
Healthcare facilities and consumers should check their inventory for the affected part number and lot codes. If a device is affected, users should follow the instructions provided by Oridion Medical or the FDA regarding the recall.
The recalled product
- Product
- CAPNOSTREAM 20 (INTL) N, Part Number CS08652
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 245
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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