Events

Retiro De Equipo (Recall) de Device Recall Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi

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
    64918
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1207-2013
  • Fecha de inicio del evento
    2012-06-08
  • Fecha de publicación del evento
    2013-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117394
  • 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 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.
  • Acción
    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

Device Recall Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Sig...
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. || Indicated for use as a diagnostic imaging device.
  • 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