SpaceLabs’ Arkon anesthesia system recalled again

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The FDA  has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units.

No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use or while idle. Emergency oxygen, vaporized agent delivery, and manual ventilation are still available.  The failed state can be cleared by powering down and restarting the system, which takes less than two minutes, according to the FDA recall notice.

SpaceLabs has not identified the reason for the failed state, the agency added.  The recalled units were manufactured between September 21, 2012 and  September 28, 2017 under the model number 99999.

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