Oridion Capnostream20 Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling 23 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. The defect involves a settings reset that could impact alarm functionality, but the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 23 units of the Capnostream20 (INTL) M W/PRINTER bedside patient monitors (model CS08660). 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, Canada, and the United Kingdom. The specific serial numbers for the recalled units are listed in the agency's recall record.
Consumers and healthcare facilities 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) M W/PRINTER, CS08660
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 23
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