Oridion Capnostream20 Patient Monitors Recalled for Settings Reset
Oridion Medical is recalling six refurbished Capnostream20 patient monitors because alarm and time 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 explicitly states no injuries or illnesses have been reported. The hazard is a functional defect (settings reset) rather than a direct physical injury risk, fitting the 'Moderate' criteria for low-risk issues without reported harm.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling six units of the Capnostream20 (INTL) N W/PRINTER REFURBISHED patient monitor (model CS78658). The recall is due to a software issue where the date/time, nurse call, and alarm settings may reset to factory default settings when the monitor is powered off.
The affected units 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 UK. The specific serial numbers for the recalled units are B200001046, B400001071, B200001463, B440112961, B200001098, and B200001752.
Healthcare facilities and users should contact Oridion Medical 1987 Ltd. for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 6
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)
- B200001046 B400001071 B200001463 B440112961 B200001098 B200001752
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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