BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2589-2018 · Initiated July 11, 2018

    Recall

    Recall Number
    Z-2589-2018
    Event Number
    80462
    Firm
    Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom
    FEI Number
    3002807992
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 11, 2018
    Posted
    August 10, 2018
    Terminated
    March 20, 2024

    Description

    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.

    Reason

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

    Action

    The firm, Spacelabs Healthcare, sent "Field Corrective Action Display Unit Resets" letters dated 7/3/2018 and 7/9/2018 to its customers via priority service on 07/11/2018. The letters informed them to circulate this notification to all affected persons and to add copies to appropriate user manuals. The firm will contact customers to replace the display assembly.. Customers with questions are encouraged to call Technical Support at 1-425-363-5212.

    Distribution

    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.

    Quantity

    328