FDA: Class I recall of Arkon Anesthesia Delivery System

Editor's Note

The Food & Drug Administration on August 10 identified the recall of Spacelabs Healthcare’s (Snoqualmie, Washington) Arkon Anesthesia Delivery System as Class I, the most serious.

The recall was issued because of the system going into a “failed state,” during which the mechanical ventilation function stops working. This can happen while the machine is in use or idle. During the failed state, the anesthesiologist cannot access mechanical ventilation or monitor ventilation.

Continued use of the system may cause serious adverse health consequences, including death.