FDA-Device2013-07-31Class II
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
Del Mar Reynolds Medical, Ltd.
Hazard
Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.
Sold states
Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
Affected count
9 units (4 in the US and 5 outside US)
Manufactured in
1-2 Harforde Ct., Foxholes, Business Park, Hertford, N/A, United Kingdom
Products
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1771-2013Don't want to check this manually?
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