Spacelabs Healthcare, Ltd. recalls Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacela…

Recall date

October 11, 2017

Source

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

Recall number

Z-0072-2018

FDA classification

Class I

Brand / firm

Spacelabs Healthcare, Ltd.

Sold / distributed

Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.

Why it was recalled

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.

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, 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 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