BEUDAMED
    FDA Recall Terminated

    Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.

    Recall: Z-1852-2014 · Initiated June 6, 2014

    Recall

    Recall Number
    Z-1852-2014
    Event Number
    68491
    Firm
    Spacelabs Healthcare Inc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 6, 2014
    Posted
    June 23, 2014
    Terminated
    February 17, 2015
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216

    Description

    Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.

    Reason

    Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.

    Action

    Spacelabs Healthcare Snoqualmie, WA sent an Urgent Medical Device Correction letter, dated June 6, 2014, to all consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter instructed customers using docking station ready qube monitors with qube docking stations immediately advise their staff of this situation; and, to follow the steps provided, if they continue to use a docking station ready qube monitor with a docking station. Spacelabs Healthcare will contact customers at the earliest possible date to schedule a convenient time for Spacelabs to correct customer's affected qube monitors at no cost. Questions should be directed to Spacelabs Healthcare Technical Support at 1-800-522-7025.

    Distribution

    Worldwide Distribution -- USA, including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and, the countries of AFG,ARE, ARG, AUS, BHR, BOL, CAN, CHE, CHL, CHN, COL, CRI, DEU, DOM, ECU, FRA, GBR, IND, ITA, JOR, KWT, LBY, MYS, NLD, OMN, PAN, POL, PRT, ROU, SAU, SGP, THA, TTO, TUN, TUR, TWN, and VNM.

    Quantity

    3383 in the USA; 1459 outside the USA