BEUDAMED
    FDA Enforcement Class II Terminated

    Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.

    Recall: Z-1608-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1608-2015
    Event ID
    71233
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2015
    Initiation Date
    May 8, 2015
    Classification Date
    May 13, 2015
    Termination Date
    November 5, 2015
    Address
    35301 SE Center St, N/A, Snoqualmie, WA, 98065-9216, United States

    Description

    Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.

    Reason

    The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).

    Code Info

    Serial Numbers: 1390-000054, 1390-000064, 1390-000313, 1390-000047, 1390-000898.

    Distribution

    distributed in North Carolina, Texas, and Wyoming

    Quantity

    5 units distributed in the US