The FDA has issued a Class I recall for GE Healthcare’s Carestation anesthesia systems.
Certain Carestation 600 and 700 series anesthesia systems with specific power management boards may shut down unexpectedly, according to a Dec. 30 FDA notice.
If power is lost, the affected systems may experience a temporary disruption of mechanical and manual ventilation, and volatile agent delivery may occur. If not addressed, loss of ventilation can be life-threatening.
GE Healthcare provided updated instructions for use to affected customers Dec. 10.
As of Nov. 26, GE Healthcare had not reported any serious injuries or deaths related to the issue, according to the notice.
