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.
A review of FDA data revealed reports of the Arkon system going into a failed state as early as March 2015. More than 100 malfunction reports by the company state that it was reporting incidents in response to an FDA letter dated Oct. 10, 2017. The agency declined to release the letter, saying it was “not publicly available.”
“The FDA is communicating with the company regarding their recalls of the Arkon system,” an agency spokeswoman wrote in an email.
Medical device manufacturers are required by law to report device malfunctions and adverse events to the FDA. The company has not responded to a request for comment. This is the third recall for SpaceLabs’ Arkon system since 2013 and the second Class I recall.