Oridion Capnostream20 M Bedside Patient Monitor Recall for Settings Reset
Oridion Medical is recalling three Capnostream20 M 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 lead to missed alarms or incorrect data, but no injuries or illnesses are reported in the source text.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling three units of the Capnostream20 M W/PRINTER CYVITAL (model CS08796) bedside patient monitors. 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, Austria, Bahrain, Belgium, Canada, and others. The specific serial codes for the affected units are B500002484, B500002616, and B500002723.
Healthcare facilities and users should contact Oridion Medical 1987 Ltd. for instructions on how to resolve the issue. The source text does not specify a particular action for consumers, but users should verify the settings on their devices and contact the manufacturer for support.
The recalled product
- Product
- Capnostream20 M W/PRINTER CYVITAL, CS08796
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 3
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)
- B500002484 B500002616 B500002723
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.
See all 37 products in this recall →Related recalls
Same manufacturer · Oridion Medical 1987 Ltd.
See all →- HighMicrostream neonatal CO2 filter lines difficult to disconnect from breathing tubes
FDA (Devices) · 2025-03-26
- HighMicrostream CO2 Sampling Line Disconnection Failure Poses Respiratory Risk
FDA (Devices) · 2025-03-26
- HighCO2 Sampling Line Adapter May Be Difficult to Disconnect; Risk of Respiratory Failure
FDA (Devices) · 2025-03-26
- HighMicrostream CO2 sampling lines recalled for difficult adapter disconnection
FDA (Devices) · 2025-03-26
- HighMicrostream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes
FDA (Devices) · 2025-03-26
Same hazard · settings reset
See all →- ModerateSiemens Atellica IM 1600 Analyzer Recalled for Custom Settings Reset
FDA (Devices) · 2020-11-25
- ModerateOridion Medical CAPNOSTREAM 20 Bedside Monitors Recalled for Settings Reset
FDA (Devices) · 2018-10-10
- ModerateOridion Capnostream20 Monitors Recalled for Settings Reset Issue
FDA (Devices) · 2018-10-10
- ModerateOridion Capnostream20 Monitors Recalled for Settings Reset Issue
FDA (Devices) · 2018-10-10
- ModerateOridion Capnostream 20P Patient Monitors Recalled for Settings Reset
FDA (Devices) · 2018-10-10