Oridion CAPNOSTREAM 20P Bedside Patient Monitors Recalled for Settings Reset
Oridion Medical is recalling 113 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 describes a functional defect (settings reset) without reporting any hospitalizations, injuries, or deaths, aligning with the 'Moderate' criteria for low-risk or precautionary issues.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 113 units of the CAPNOSTREAM 20P (INTL) N bedside patient monitor, Part Number CS08652-01. The recall was initiated because the date, time, nurse call, and alarm settings on the 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, Canada, Germany, Japan, and the United Kingdom. Specific lot codes for the affected units are listed in the official recall documentation.
Healthcare facilities and consumers should check their inventory for the specific part number and lot codes associated with this recall. If a device is affected, users should contact Oridion Medical for instructions on how to proceed, as the device may not retain critical alarm and time settings during power cycles.
The recalled product
- Product
- CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 113
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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