The FDA recalled SpaceLabs Healthcare's Arkon anesthesia delivery system for going into a "failed state."
1. The Class 1 recall covers 253 units manufactured between Sept. 21, 2012, and Sept. 28, 2017. A Class 1 recall is the most serious type of recall.
2. The Arkon system is designed to deliver oxygen, air and nitrous oxide to patient breathing circuits in hospitals and operating rooms. It may also be used to deliver of anesthetic vapor.
During the failed state, anesthesiologists can't access the mechanical ventilation function while the machine is in use or idle. Emergency oxygen, vaporized agent delivery and manual ventilation remain functional.
3. Anesthesiologists can clear the failed state by powering down and restarting the system. This process takes less than two minutes.
4. SpaceLabs has not received reports of any injuries or deaths, but the FDA alert warns continued use of the product could cause both.
5. This is the third time for SpaceLabs' Arkon system has been recalled since 2013, according to Mass Device. It is the system's second Class I recall.