BEUDAMED
    FDA Recall Terminated

    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

    Recall: Z-1442-2014 · Initiated March 10, 2014

    Recall

    Recall Number
    Z-1442-2014
    Event Number
    67781
    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 in the Use Environment
    Initiated
    March 10, 2014
    Posted
    April 12, 2014
    Terminated
    August 20, 2014

    Description

    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

    Reason

    The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.

    Action

    Spacelabs Healthcare sent an Urgent Medical Device Correction letter, dated 11 March 2014, to consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter stated that Spacelabs Field Service personnel will be contacting consignees to schedule a convenient time to install, at no cost, a software upgrade. Consignees with questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

    Distribution

    USA Nationwide Distribution in the states of North Carolina and South Carolina

    Quantity

    16 units distributed in the US