Oridion Medical CAPNOSTREAM 20P Bedside Patient Monitor Recall
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 potential loss of critical alarm and nurse call settings, which poses a risk of harm to patients if the device fails to alert staff, although no specific injuries are reported in the source text.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 474 units of the CAPNOSTREAM 20P (INTL) N - ROHS bedside patient monitors, Part Number CS08652-02. 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 codes listed in the official FDA record Z-0038-2019.
Healthcare facilities and consumers should check their inventory for the affected part number and lot codes. If a device is found, it should be removed from service and returned to Oridion Medical or the distributor for repair or replacement as directed by the manufacturer.
The recalled product
- Product
- CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 474
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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