Medical Device Safety and Recalls: Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System with Version 2.0 Software - Software Defect May Cause System to Stop Working

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System with Version 2.0 Software - Software Defect May Cause System to Stop Working

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 also cause the System to stop working.  For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm393536.htm

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