Class I Recall: Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System

The U.S Food and Drug Administration (FDA) just announced that Spacelabs Healthcare Ltd. has recalled its ARKON Anesthesia Delivery System with Version 2.0 Software. A software defect may cause the system to cease working. The FDA has deemed the recall a Class I, its most serious designation, which is reserved for situations in which there exists a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.

The recalled ARKON Anesthesia Delivery Systems were manufactured and distributed from March 18, 2013 through June 17, 2013; 16 units were distributed to hospitals in North Carolina and South Carolina. The ARKON Anesthesia Delivery System with Version 2.0 Software includes the following serial numbers of units distributed in the United States:

• 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
• ARKN-000031

The Spacelabs ARKON Anesthesia Delivery System is used in hospital operating rooms and may used for the controlled delivery of oxygen, air, and nitrous oxide to various patient breathing circuits, with or without the use of a mechanical ventilator. The system may also be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The primary users of the ARKON Anesthesia Delivery System are qualified physicians.

The software defect discovered in the Spacelabs Healthcare ARKON Anesthesia System with Version 2.0 Software may cause the system to stop working, which may require manual ventilation of patients. If a cell phone or other USB device is plugged into one of the four USB ports for charging, this may also cause the system to stop working. The software defect may lead to serious adverse health consequences, including hypoxemia and death. To date, Spacelabs Healthcare has received one report associated with the software defect; no injuries or deaths have been associated with this malfunction.

Spacelabs Healthcare of Snoqualmie, Washington sent customers an Urgent Medical Device Correction letter on March 11, 2014 and followed up with a letter on March 26, 2014. The letters identified the product, the problem, and the action to be taken by the customer. 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 advised health care facilities with ARKON Anesthesia Delivery Systems that:

• If the system is used, the spirometry loops should not be saved until Spacelabs has corrected the software defect. The error is triggered by the combination of a spirometry loop save and a change in waveform configuration.
• If the system is used, the USB ports are not to be used until the ARKON software has been updated.
• If the error does occur, a buzzer will sound and a warning icon will appear on the main display screen. The user should switch to emergency O2 and manually ventilate the patient until they can safely remove the system from patient use.
• If power is cycled, the system will re-boot in about 3 minutes and recover from the software anomaly; mechanical ventilation may then be continued.
• If health care providers have questions about this corrective action program, Spacelabs Healthcare may be reached, toll-free, at 1.800.522.7025 (select 2 for Technical Support).