BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.

    Recall: Z-0814-2013 · Initiated June 13, 2012

    Recall

    Recall Number
    Z-0814-2013
    Event Number
    63662
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 13, 2012
    Posted
    February 14, 2013
    Terminated
    August 25, 2016
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.

    Reason

    GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.

    Action

    GE Healthcare sent an Important Product Information Letter dated June 13, 2012 via FedEx to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter indicated that the motherboard would be replaced, on request, should the customer continue to experience the issue. A second letter dated August 30th 2012 was issued informing consignees that the correction that was initially proposed did not fully correct the issues. Therefore, the motherboard replacement field action had been suspended. It further explained that the correction will be provided at no charge when it is available. For questions contact Technical Support at 1-800-558-7044.

    Distribution

    Worldwide Distribution and US (nationwide) including DC and the countries of ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, INDIA, ISRAEL, ITA LY, JAPAN, JORDAN, KUWAIT, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH KOREA, SPAIN SWEDEN SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.

    Quantity

    10,497