Serial numbers of units distributed in the U.S. ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031
AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Managers, Nursing
ISSUE: Spacelabs Healthcare is recalling the ARKON Anesthesia System with Version 2.0 Software due to a software defect. This 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.
This defect may cause serious adverse health consequences, including hypoxemia and death. Spacelabs Healthcare received one report related to the software defect. Affected products were manufactured and distributed from March 18, 2013 through June 17, 2013. Sixteen units were distributed to hospitals in North Carolina and South Carolina.
BACKGROUND: The Spacelabs 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. The primary users of this device are qualified physicians.
RECOMMENDATION: Spacelabs Field Service personnel are contacting customers affected by this recall to schedule a free software update installation that may resolve this issue. Until the software updates are installed, Spacelabs Healthcare provided the following recommendations for health care facilities with ARKON Anesthesia Delivery Systems:
For questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
[03/10/2014 - Recall Notice - FDA]