BEUDAMED
    FDA Recall Terminated

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), 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. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    Recall: Z-1145-2015 · Initiated January 28, 2015

    Recall

    Recall Number
    Z-1145-2015
    Event Number
    70453
    Firm
    Spacelabs Healthcare Inc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 28, 2015
    Posted
    February 24, 2015
    Terminated
    December 30, 2015
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216

    Description

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), 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. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    Reason

    Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following power on or reset.

    Action

    Spacelabs began to send the Urgent Medical Device Correction XPREZZON Bedside Monitor, Model 91393 qube Compact Monitor, Model 91390 letter, dated 28, January 2015, to US consignees. Spacelabs began sending the Urgent Medical Device Correction XPREZZON Bedside Monitor, Model 91393 qube Compact Monitor, Model 91390 letter (translated as necessary) to international customers via email on 2/4/15. Actions to be Implemented by Users: -Do not rely solely on the monitor for critically ill patients. -If customer facility operates any XPREZZON or qube monitors on a standalone basis, rather than via central monitoring, please contact Spacelabs technical support as these monitors will be the first repaired. Spacelabs Healthcare will contact consignees to schedule a convenient time for Spacelabs to replace the PCBAs in all of your facility's affected XPREZZON and qube monitors at no cost. If you have any questions about this corrective action, please contact Spacelabs at the toll free number of 1-800-522-7025 and select 2 for Technical Support, or via direct dial at 1-425-363-5203.

    Distribution

    Worldwide Distribution.

    Quantity

    total 2955 units (2117 units in US and 838 units outside US)