Recall of Device Recall Signa Excite" 1.5 T Magnetic Resonance Systems, GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57142
  • Event Risk Class
    Class 2
  • Event Number
    Z-0462-2011
  • Event Initiated Date
    2009-05-11
  • Event Date Posted
    2010-11-24
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-11-24
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • 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.

Device

  • Model / Serial
    SERIAL 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Signa¿ Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
  • Source
    USFDA