Spacelabs Healthcare, Ltd. recalls Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Mod…

Recall date

July 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2589-2018

FDA classification

Class I

Brand / firm

Spacelabs Healthcare, Ltd.

Sold / distributed

Worldwide Distribution: U.S (nationwide) to states of.: LA, NE, CO, WY, MT, NM, IN, ME, NY, IL, MA, TX, PA, PR; and countries (OUS) of: PERU BOLIVIA, PANAMA, MALAYSIA, POLAND, IRELAND, MOROCCO, MEXICO, CANADA, UNITED KINGDOM, FRANCE, and CHINA, ECUADOR.

Why it was recalled

Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. 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 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. The device is intended for use only by a suitably qualified physician.