BEUDAMED
    FDA Enforcement Class II Terminated

    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation 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: Z-1771-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1771-2013
    Event ID
    65630
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Del Mar Reynolds Medical, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    June 7, 2013
    Classification Date
    July 19, 2013
    Termination Date
    August 29, 2013
    Address
    1-2 Harforde Ct., Foxholes, Business Park, Hertford, N/A, N/A, United Kingdom

    Description

    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation 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.

    Reason

    Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.

    Code Info

    ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.

    Distribution

    Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.

    Quantity

    9 units (4 in the US and 5 outside US)