Events

Retiro De Equipo (Recall) de Discovery MR750w 3.0T System

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
    64763
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1100-2013
  • Fecha de inicio del evento
    2012-04-23
  • Fecha de publicación del evento
    2013-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117007
  • 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 recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your discovery mr750w system. image flip issue in frequency encoding direction (including s/i, a/p and r/l) can result in incorrect localization of anatomy and pathological findings.
  • Acción
    GE Healthcare sent an Important Product Information letter dated April 23, 2012. The letter described the Issue, Instructions, Affected Product Details and Product Correction. For questions contact your local service representative.

Device

Discovery MR750w 3.0T System
  • Modelo / Serial
    Serial Number 00000000UA0027 00000000UA0012 00000000UA0029 00000000UA0031 00000000UA0030 00000000UA0028 00000000UA0034 00000000UA0038 00000000UA0048 00000000UA0046 00000000UA0052 00000000UA0041 00000000UA0011A 00000000UA0055 00000000UA0056 00000000UA0057 00000000UA0064 00000000UA0053 00000000UA0044 00000000UA0047 00000000UA0010 00000000UA0013 00000000UA0017 00000000UA0042 00000000UA0016 00000000UA0019 00000000UA0015 00000000UA0058 00000000UA0051 00000000UA0025 00000000UA0024 00000000UA0020 00000000UA0040 00000000UA0018 00000000UA0036 00000000UA0043 00000000UA0054 00000000UA0022 00000000UA0023 00000000UA0045 00000000UA0039 00000000UA0035 00000000UA0049 00000000UA0021 00000000UA0033 00000000UA0037
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, IL, MD, NJ, NY, OH, OK, TX. and the countries of Australia, Belarus, Canada, France, Germany, India, Japan, Lebanon, New Zealand, Saudi Arabia, Singapore, Spain, Sweden, Switzerland and United Kingdom.
  • Descripción del producto
    GE Healthcare, Discovery MR750w 3.0T System. || Part Number: 5352293. || Product Usage: 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.
  • 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