Oridion Capnostream 20P Bedside Patient Monitor Recall for Settings Reset
Oridion Medical is recalling 56 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, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a functional defect (settings reset) without explicit reports of harm, fitting the Moderate category for low-risk or precautionary issues.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 56 units of the CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03 bedside patient monitors. The recall is due to a defect where the date, time, nurse call, and alarm settings 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 specific lot codes for the recalled units range from PM31170001 to PM37170056.
Consumers and healthcare facilities should check their inventory for these specific lot codes. If a unit is affected, they should contact Oridion Medical 1987 Ltd. for instructions on how to proceed with the recall.
The recalled product
- Product
- CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 56
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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