BEUDAMED
    FDA Recall Terminated

    GE Signa Advantage nuclear magnetic resonance imaging system.

    Recall: Z-0858-06 · Initiated August 19, 2005

    Recall

    Recall Number
    Z-0858-06
    Event Number
    33320
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 19, 2005
    Posted
    May 10, 2006
    Terminated
    February 3, 2007
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Signa Advantage nuclear magnetic resonance imaging system.

    Reason

    During use of GE Signa nuclear magnetic resonance imaging system, a flexible Teflon tube that was part of the magnet vent system ruptured and allowed the magnet to vent into the scan room. Because of helium pressure inside the room, the scan room door could not be reopened after the patient was removed from the scan room.

    Action

    GE Healthcare is issuing an Urgent Safety Notification to all affected customer sites beginning 09/01/05. The notification describes the concurrent condition that must exist in order for the event to occur. Users are warned to be present at all times when scanning patients and to take emergency measures to vent the scan room should the magent quench. Beginning September 2005, all affected customers'' devices will have the Teflon venting tube replaced with a nonflexible venting tube.

    Distribution

    Nationwide and to countries OUS including: United Arab Emirates, Argentina, Australia, Brazil, Canada, China, Germany, Denmark, Egypt, Spain, France, United Kingdom, Ireland, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, Saudi Arabia, Sweden, Turkey and Tiawan

    Quantity

    644 (516 US, 128 OUS)