Oridion Medical CAPNOSTREAM 20P Monitors Recalled 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
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, and the hazard involves a functional defect (settings reset) that could impact patient monitoring but does not involve reported injuries or immediate life-threatening failure.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 383 units of the CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS 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 specific lot codes for the recalled units are listed in the official FDA recall record Z-0042-2019.
Healthcare facilities and users should check their inventory for the affected lot codes and contact Oridion Medical for instructions on how to proceed with the recall.
The recalled product
- Product
- CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 383
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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