Oridion CAPNOSTREAM 20P Bedside Patient Monitor Recall for Settings Reset
Oridion Medical is recalling 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 the resetting of critical alarm settings on a medical device, which poses a risk of harm to patients even though no specific injuries are reported in the source text.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 1,819 units of the CAPNOSTREAM 20P (US) N bedside patient monitor, Part Number CS08651-01. 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 recall covers specific lot codes listed in the official FDA record.
Healthcare facilities and consumers should check their devices against the list of affected lot codes. If a device is affected, users should contact Oridion Medical for instructions on how to proceed, as the resetting of alarm settings could impact patient monitoring safety.
The recalled product
- Product
- CAPNOSTREAM 20P (US) N, Part Number CS08651-01
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 1,819
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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