GE Healthcare has issued a Class I recall of its single-width airway modules and accessories and extension modules, due to the CO2 detectors failing or providing incorrect CO2 values for mechanically and spontaneous ventilated patients.
The device failures could lead to increased or decreased values of CO2, which could be fatal, according to a U.S. Food and Drug Administration news release. Additionally, physicians may make clinical decisions based off incorrect displayed values, potentially causing permanent impairment or life-threatening changes.
Currently there have been no reports of injury or death associated with the recalled device, according to the news release.
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