Events

Recall of Discovery MR750w /MR750, Optima MR450w, Discovery MR450, 1.5/3T Signa HDxt, Signa Vibrant.

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
    65992
  • Event Risk Class
    Class 2
  • Event Number
    Z-2266-2013
  • Event Initiated Date
    2013-04-09
  • Event Date Posted
    2013-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121160
  • 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 potential safety issue due to non-unique series identifiers embedded in image headers of certain ge mr products. for clariview and screen save from gvtk (gems visualization toolkit) viewer, the mr product can generate image headers with non-unique series identifiers, which when exported to some pacs systems, results in the series being associated wit.
  • Action
    Customers were sent two GE Healthcare "Urgent Medical Device Correction" letters one dated April 9, 2013, and the other May 22, 2013, each addressing one of the 2 groups of MR Products involved in the recall. The letters were addressed to Hospital Administrators / Risk managers, Radiology Department Mangers and Radiologists. The letters described the Safety Issue and provided Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected systems by providing a software update at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. Contact your local service representative if you have any questions concerning this notification. For further questions please call (262) 513-4122.

Device

Discovery MR750w /MR750, Optima MR450w, Discovery MR450, 1.5/3T Signa HDxt, Signa Vibrant.
  • Model / Serial
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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - All states in continental USA including DC except AK, AZ, RI and WY. and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEANON, MARINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, LUXEMBOURG, PORTUGAL, VIETNAM and URUGUAY.
  • Product Description
    GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. || GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. || The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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