Oridion Capnostream 20P Patient Monitors Recalled for Settings Reset
Oridion Medical is recalling 696 Capnostream 20P 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 illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 696 units of the CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03. The recall was initiated because the date/time, nurse call, and alarm settings of the bedside patient monitors 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, Austria, Bahrain, Belgium, Canada, and others. The recall covers specific lot numbers ranging from PA10170221 to PA36173715.
Healthcare facilities and consumers should check their inventory for the affected part number and lot codes. If a unit is identified, it should be removed from service and returned to Oridion Medical 1987 Ltd. for repair or replacement in accordance with the recall instructions.
The recalled product
- Product
- CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 696
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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