Spacelabs Healthcare is recalling the Arkon Anesthesia System with Version 2.0 Software due to a software defect that may cause serious adverse health consequences, including hypoxemia and death, according to an FDA announcement.
The software issue may cause the system to stop working and require manual ventilation of patients. In addition, if a cell phone or other USB device is plugged into one of the four USB ports for charging, this may cause the system to stop working.
The Arkon Anesthesia Delivery System is used in hospital operating rooms. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.