BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0072-2018 · Initiated October 11, 2017

    Recall

    Recall Number
    Z-0072-2018
    Event Number
    78330
    Firm
    Spacelabs Healthcare, Ltd. Foxholes Centre, Unit B John Tate Road Hertford United Kingdom
    FEI Number
    3002807992
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 11, 2017
    Posted
    November 21, 2017
    Terminated
    March 12, 2018

    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

    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.

    Distribution

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

    Quantity

    110 units