Oridion CapnoStream 20P Bedside Patient Monitors Recalled for Settings Reset
Oridion Medical is recalling 1,038 CapnoStream 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (patient monitor) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 1,038 units of the CAPNOSTREAM 20P (US) N W/PRINTER bedside patient monitors, Part Number CS08657-01. 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 serial numbers listed in the official FDA record.
Healthcare facilities and consumers should check their inventory for the affected serial numbers. If a device is found, 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, Part Number CS08657-01
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 1,038
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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