Oridion Capnostream20 Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling Capnostream20 bedside 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 settings resetting to defaults, which is a functional defect without reported injuries or deaths, fitting the Moderate criteria for low-risk or precautionary issues.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling Capnostream20 (US) M TO MASIMO bedside patient monitors, Part Number CS08750. 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, Canada, and the United Kingdom. The specific code for the affected units is B500002658.
Consumers and healthcare facilities should contact Oridion Medical 1987 Ltd. for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Capnostream20 (US) M TO MASIMO, Part Number CS08750
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- B500002658
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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