GE Healthcare is recalling the Carestation 620/650/650c A1 anesthesia systems because there is a potential for a loose cable connection inside the system which may cause the mechanical ventilation to stop working. If this occurs, the system will emit a high priority audio and visual alarm to alert the health care provider. Loss of mechanical ventilation could lead to low (hypoxia) blood oxygen levels in the patient if the health care provider does not ventilate the patient manually or with an alternate system.
The use of the affected product may cause the patient to have low blood oxygen levels, which could result in tissue or organ damage, or death.
There were no reported injuries or deaths.
For more information, visit the FDA website.
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