BEUDAMED
    FDA Recall Terminated

    Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.

    Recall: Z-0462-2011 · Initiated May 11, 2009

    Recall

    Recall Number
    Z-0462-2011
    Event Number
    57142
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 11, 2009
    Posted
    November 24, 2010
    Terminated
    November 24, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.

    Reason

    Signa MR Excite" 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip along the phase encode direction and incorrect annotation, which may result in incorrect localization of anatomy in oblique axial images with the pulse sequences.

    Action

    GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 21, 2009. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Field Engineers will contact customers to schedule a field modification of the affected products to address this issue. Customers can contact GE Healthcare at 262 521-6100 about this issue.

    Distribution

    Worldwide Distribution: Throughout USA except states of AK, VT and WY, and the countries of: Argentina, Australia, Bulgaria, Brazil, China, Canada, Switzerland, Chile, Colombia, Czech Republic, Ecuador, Egypt, Spain, Finland, France, Great Britain, Guatemala, Honduras, Croatia, Hungary, Indonesia, Ireland, India, Iran, Iceland, Italy, Japan, Kenya, South Korea, Kuwait, Lebanon, Luxembourg, Libya, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Puerto Rico, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Syria, Thailand, Tunisia, Turkey, Taiwan, Venezuela, and South Africa.

    Quantity

    1464