FDAOctober 11, 2017device
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controll...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.
What to do
FDA enforcement status: Terminated
Brands named
spacelabs healthcarespacelabs
UPCs
10841522100017
Recall history
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