The U.S. Food and Drug Administration announced that the ARKON Anesthesia System with version 2.0 software, by SpaceLabs HealthCare, has been recalled.
The system has been recalled due to a software defect that may cause the system to stop working and require manual ventilation of patients. Also, if a cell phone or other USB device is plugged into one of the USB ports for charging, it may cause the system to stop working. This defect may cause serious adverse health consequences, including hypoxemia and death.
Spacelabs Healthcare field service personnel are contacting customers affected by this recall to schedule a free software update installation that may resolve this issue, according to the FDA.
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The system has been recalled due to a software defect that may cause the system to stop working and require manual ventilation of patients. Also, if a cell phone or other USB device is plugged into one of the USB ports for charging, it may cause the system to stop working. This defect may cause serious adverse health consequences, including hypoxemia and death.
Spacelabs Healthcare field service personnel are contacting customers affected by this recall to schedule a free software update installation that may resolve this issue, according to the FDA.
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