BEUDAMED
    FDA Recall Terminated

    The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.

    Recall: Z-0196-2013 · Initiated October 5, 2012

    Recall

    Recall Number
    Z-0196-2013
    Event Number
    63506
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    October 5, 2012
    Posted
    November 5, 2012
    Terminated
    March 25, 2013
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.

    Reason

    Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.

    Action

    Spacelabs Healthcare sent a URGENT - MEDICAL DEVICE CORRECTION letter dated October 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to advise their staff of this potential failure and advise them to ensure the alarm lights are functional. The firm will contact the consignee at the earliest possible date to schedule a convenient time for the hospital to upgrade the affected product at no cost. Customers can call Technical Support at 1-800-522-7025 and select 2 for any questions about this recall.

    Distribution

    Worldwide Distribution--US (nationwide) including states of Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas., and the countries of Canada, Chile, France, Libya, Panama, Qatar, Saudi Arabia, Switzerland and United Kingdom

    Quantity

    169 units distributed (98 in US and 71 Internationally)