Events

Recall of Arkon Anesthesia Delivery System and Upgrade Kit 050904300

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare, Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78330
  • Event Risk Class
    Class 1
  • Event Number
    Z-0072-2018
  • Event Initiated Date
    2017-10-11
  • Event Date Posted
    2017-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159202
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gas-machine, anesthesia - Product Code BSZ
  • 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.
  • Action
    Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2017. The letter identified the affected product problem and actions to be taken. For questions call 1-800-522-7025 and select 4 for Technical Support.

Device

Arkon Anesthesia Delivery System and Upgrade Kit 050904300
  • Model / Serial
    UDI: 10841522100017
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
  • Product Description
    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
  • Manufacturer
    Spacelabs Healthcare, Ltd.

Manufacturer

Spacelabs Healthcare, Ltd.
  • Manufacturer Address
    Spacelabs Healthcare, Ltd., Foxholes Centre, Unit B, John Tate Road, Hertford United Kingdom
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA