Events

Recall of Device Recall GE Healthcare Discovery MR450 1.5T

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
    57270
  • Event Risk Class
    Class 2
  • Event Number
    Z-1376-2011
  • Event Initiated Date
    2010-11-18
  • Event Date Posted
    2011-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95714
  • 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 become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your mr750, mr450, and mr450w mr systems that may impact service or maintenance personnels safety. the gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the grad.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information. Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures. Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.

Device

Device Recall GE Healthcare Discovery MR450 1.5T
  • Model / Serial
    00000XRMBB0091 00000XRMBB0101 00000XRMBB0096 00000XRMBB0111 00000XRMBB0100 00000XRMBB0063 00000XRMBB0094 00000XRMBB0099 00000XRMBB0121 00000XRMBB0122 00000XRMBB0125
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, LA, MD, MA, MI, MO, NV, NJ, NY, NC, OR, PA, SC, TN, TX, WA, WI. and the countries of AUSTRALIA, BRAZIL, CANADA, EHYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, ITALY, JAPAN, KUWAIT, QATAR, REPUBLIC OF KOREA, SWITZERLAND, TAIWAN, and the UNITED KINGDOM.UNITED KINGDOM, TAIWAN, SWITZERLAND, REPUBLIC OF KOREA, QATAR, KUWAIT, JAPAN, ITALY, INDIA, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, CANADA, BRAZIL, AUSTRALIA.
  • Product Description
    GE Healthcare Discovery MR450 1.5T, || The Discovery MR450 is 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; The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
  • 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