Oridion CapnoStream 20P Patient Monitors Recalled for Settings Reset
Oridion Medical is recalling 192 CapnoStream 20P 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 the potential loss of critical alarm and nurse call settings on a medical device, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 192 units of the CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, model CS08658-03, bedside patient monitors. 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, Austria, Bahrain, Belgium, Canada, and others. The recall covers specific lot numbers ranging from PA14170895 to PA24172472.
Consumers and healthcare facilities should check their inventory for the affected model and lot numbers. If a device is found, it should be removed from service and the manufacturer contacted for instructions on repair or replacement.
The recalled product
- Product
- CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 192
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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