ARKON Anesthesia System Recalled

April 17, 2014 — Spacelabs Healthcare is recalling the ARKON Anesthesia System due to a defect in Version 2.0 Software. The defect may cause the system to stop working and require manual ventilation of patients. In addition, if a cell phone or other device is plugged into the USP port for charging, the anesthesia system could stop working.

The U.S. Food and Drug Administration (FDA) has issued a Safety Alert about the risk of life-threatening complications, including hypoxemia (low oxygen in the blood), which can cause death. Spacelabs has received one report linked to the software defect.

The recall affects 16 units were sold to hospitals in North Carolina and South Carolina between March 18, 2013 and June 17, 2013.

What is the ARKON Anesthesia Machine?

Spacelabs manufactures the ARKON Anesthesia Delivery System, which is used in hospitals and operating rooms. The system is used to deliver oxygen, air, and nitrous oxide to patients in a controlled manner. It can be used with or without a mechanical ventilators. It may be used to deliver anesthetic vapor with a dismountable vaporizer.

What Should I Do?

Spacelabs is contacting customers who own ARKON Anesthesia Delivery Systems affected by the recall to schedule a service appointment to install a free software update. Until the software update is installed, Spacelabs recommends taking the following precautions:

• If you continue to use your ARKON Anesthesia System, we recommend that you do NOT save spirometry loops until Spacelabs has remedied the software defect. The error is triggered by the combination of a spirometry loop save and a change in waveform configuration.
• Advise users NOT to use the USB ports until after your ARKON software is updated.
• If the error does occur, the user will hear a buzzer and a warning icon will appear on the main display screen. We recommend that the user switch to emergency oxygen and manually ventilate the patient until such time as they can safely remove the system from patient use.
• If you cycle power, the system will reboot in roughly 3 minutes and recover from the above software anomaly and mechanical ventilation can continue.

For questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

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