Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare Discovery MR450 1.5T

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57270
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1376-2011
  • Fecha de inicio del evento
    2010-11-18
  • Fecha de publicación del evento
    2011-02-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95714
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    00000XRMBB0091 00000XRMBB0101 00000XRMBB0096 00000XRMBB0111 00000XRMBB0100 00000XRMBB0063 00000XRMBB0094 00000XRMBB0099 00000XRMBB0121 00000XRMBB0122 00000XRMBB0125
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA