BEUDAMED
    FDA Recall 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 · Initiated June 7, 2013

    Recall

    Recall Number
    Z-1771-2013
    Event Number
    65630
    Firm
    Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom
    FEI Number
    3002807992
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 7, 2013
    Posted
    July 19, 2013
    Terminated
    August 29, 2013

    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.

    Action

    Spacelabs Healthcare sent an Urgent Medical Device Correction" letter, dated June 20, 2013, to all affected consignees. The letter identified the product, th problem, and the action to be taken by the consignee. Consignees were instructed to advise their staff of the situation. Consignees were also advised that Spacelabs Field Service personnel would be contacting them at their facility to schedule installation of a software update to resolve the issue at not cost to the consignee. Consignees with questions were instructed to call Technical Support at 1-800-522-7025 and select option 2. For questions regarding this recall call 800-522-7025.

    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)