BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-1442-2014 · Reported April 23, 2014

    Enforcement

    Recall Number
    Z-1442-2014
    Event ID
    67781
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Del Mar Reynolds Medical, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2014
    Initiation Date
    March 10, 2014
    Classification Date
    April 11, 2014
    Termination Date
    August 20, 2014
    Address
    1-2 Harforde Ct., Foxholes, Business Park, Hertford, N/A, N/A, United Kingdom

    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.

    Code Info

    SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.

    Distribution

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

    Quantity

    16 units distributed in the US