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.
A GE Healthcare spokesperson provided the following statement to Becker’s:
“Patient safety is our top priority. After identifying a potential issue with certain Carestation 600 and 700 Series anesthesia delivery systems that may temporarily disrupt ventilation in the event of power loss, we are providing hospitals with instructions to follow to continue use of their devices. We will be correcting all impacted systems. There have been no reports of patient injury as a result of this potential issue.”
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