BEUDAMED
    FDA Recall Terminated

    The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured by ELo Touchsystems

    Recall: Z-0288-2011 · Initiated October 23, 2009

    Recall

    Recall Number
    Z-0288-2011
    Event Number
    53863
    Firm
    Spacelabs Healthcare, Incorporated
    FEI Number
    3010157426
    Product Code
    DXJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 23, 2009
    Posted
    November 2, 2010
    Terminated
    November 3, 2010
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured by ELo Touchsystems

    Reason

    The Spacelabs Medical Flat Panel Display, Model 94260-19 may fail prematurely and causing the screen to go blank. This inability to view data may result in delayed patient treatment.

    Action

    On 10/23/09, Spacelabs issued URGENT: MEDICAL DEVICE RECALL notification letters dated October 23, 2009 to their consignees. The notification states the recalled product as Spacelabs Medical 19" Flat Panel Display, Model 94260-19. The consignees are informed that there is a possibility that the internal power distribution circuit board will fail prematurely, causing the display to go blank. Audio alarms will continue to function normally. The firm's Field Service Engineer will be contacting the consignees to set up a convenient time to schedule the upgrades of the affected displays. Displays with part number ET1920L-7SKR-1-35S-SPC are not part of this recall and should not be sent in for upgrading. The firm recommends that their consignees brief their staff on the possibility of the display going blank to help prevent an adverse event from happening. The firm will be providing loaners while the affected displays are upgraded at free of charge. If the consignees have any questions about the recall, they could contact Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support . Consignees outside the United States may call 1-425-657-7200 x 5089.

    Distribution

    Worldwide Distribution: USA in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY, and the following countries: Australia, Austria, Canada, Czech Republic, Egypt, France, Germany, Grand Cayman, Greece, India, Israel, Italy, Kuwait, Lebanon, Mexico, Netherlands, Pakistan, Panama, Poland, Puerto Rico, Saudi Arabia, Singapore, Slovakia , South Africa, Switzerland, Trinidad and Tobago, Turkey, United Kingdom, and Venezuela.

    Quantity

    2560 units (2020 domestic, 540 international)