Oridion CAPNOSTREAM 20 Patient Monitors Recalled for Settings Reset
Oridion Medical is recalling 3,143 CAPNOSTREAM 20 patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential loss of critical alarm and nurse call settings, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling 3,143 units of the CAPNOSTREAM 20 (US) N patient monitor, Part Number CS08651. The recall was initiated because the date, time, nurse call, and alarm settings on the bedside patient monitors 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 recall covers specific lot codes identified in the agency's records.
Healthcare facilities should check their inventory for the affected part number and lot codes. If a monitor is affected, it should be removed from service and returned to Oridion Medical 1987 Ltd. for repair or replacement.
The recalled product
- Product
- CAPNOSTREAM 20 (US) N, Part Number CS08651
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 3,143
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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