29

Nov

2017

Class I Arkon Anesthesia Delivery System

0

Company:Spacelabs Healthcare, Ltd.
Date of Enforcement Report 11/29/2017
Class l:

PRODUCT

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.
Recall Number Z-0072-2018

REASON
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

RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Ltd., Hertford UK on 10/11/2017. Voluntary firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
110 units

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

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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