Recall of Device Recall GE 1.5T SIGNA HDe MR SYSTEM

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
    64918
  • Event Risk Class
    Class 2
  • Event Number
    Z-1208-2013
  • Event Initiated Date
    2012-06-08
  • Event Date Posted
    2013-05-01
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2014-11-03
  • 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
    Ge healthcare has recently become aware of a reformat image flip issue associated with ge mr products. the axial and coronal reformatted images from a sagittal 3d series (such as with applications of fspgr-3d t1, bravo t1, or cube t1) of over 126 slices may display a left-to-right image flip . in addition, the acquired sagittal images may be annotated with left-right location annotation revers.
  • Action
    GE Healthcare sent an "Important Product Information" letter dated June 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their local service representative for questions regarding this notice.

Device

  • Model / Serial
    Mfg Lot or Serial 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.
  • Product Description
    GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. || Indicated for use as a diagnostic imaging device.
  • Manufacturer

Manufacturer

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