FDANovember 25, 2019device
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
What to do
FDA enforcement status: Terminated
Brands named
ge healthcare
UPCs
10129620000
Recall history
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