Oridion Capnostream20 N Monitors Recalled for Settings Reset Issue
Oridion Medical is recalling five Capnostream20 N bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 reset of critical alarm and nurse call settings, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling five units of the Capnostream20 N W/PRINTER CYVITAL (CS08798) 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 in the United States, Puerto Rico, and numerous foreign countries. The specific serial numbers for the recalled units are B400002649, B400002619, B400002624, B400002632, and B400002641.
Healthcare facilities should contact Oridion Medical for instructions on how to resolve the issue. This recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Capnostream20 N W/PRINTER CYVITAL, CS08798
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 5
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)
- B400002649 B400002619 B400002624 B400002632 B400002641
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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