BEUDAMED
    FDA Recall Terminated

    Power supply boards on Dash 3000, 4000 and 5000 Monitors. GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223.

    Recall: Z-0359-2011 · Initiated October 11, 2010

    Recall

    Recall Number
    Z-0359-2011
    Event Number
    56664
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 11, 2010
    Posted
    November 15, 2010
    Terminated
    May 29, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Power supply boards on Dash 3000, 4000 and 5000 Monitors. GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223.

    Reason

    The power supply board in GE Healthcare Dash 3000, 4000 and 5000 patient monitors may fail due to insufficient solder of a component. Insufficient solder on the power supply board could result in excess EMC emissions, smoking of components and eventual failure of the power supply, tripping of the fuse and immediate shutdown resulting in a loss of monitoring that could delay recognition of a clinic

    Action

    GE Healthcare issued an "Urgent Medical Device Correction" letter dated October 8, 2010, which described the loss of monitoring issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Customers were instructed to remove the units from use. Local service representatives will contact firms to schedule installation of replacement power supply boards. GE Healthcare can be contacted at 1-800-558-7044, Option 2, Technical Support, about this correction.

    Distribution

    Worldwide Distribution: USA in the states of IL, NV, TX, and VA, and the countries of Australia, Brazil, China, Japan, South Korea, and Taiwan.

    Quantity

    137