Events

Retiro De Equipo (Recall) de Device Recall DISCOVERY MR450

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
    59232
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3123-2011
  • Fecha de inicio del evento
    2011-07-29
  • Fecha de publicación del evento
    2011-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102278
  • 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 of two potential safety issues associated with mr products (optima mr450w, discovery mr450, discovery mr750, brivo mr355, optima mr360) that may impact patient safety. 1) inline post-processed (i.E. automated post-processing) image locations are not correctly annotated under some conditions. 2) reference images displayed in functool fibertrak do not match with.
  • Acción
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated July 27, 2011 to customers with affected systems. The letter described the recalled product, safety issues and recommended actions to be taken. The letter provided immediate mitigation (Safety Instuctions) that address each issue. The letter states that the recalling firm will contact customers to arrange to provide a software upgrade to all affected systems at no cost. For any questions concerning this notification contact your local service representative.

Device

Device Recall DISCOVERY MR450
  • Modelo / Serial
    00000299294MR9 00000299320MR2 00000299339MR2 00000299491MR1 00000299503MR3 00000299520MR7 00000299522MR3 00000299559MR5 00000299560MR3 00000299627MR0 00000299634MR6 00000299644MR5 00000299645MR2 00000299647MR8 00000299683MR3 00000299823MR5 00000299851MR6 00000299852MR4 00000299952MR2 00000300038MR7 00000300473MR6 00000300493MR4 00000300494MR2 00000300564MR2 00000300565MR9 00000300571MR7 00000300572MR5 00000300588MR1 00000300590MR7 00000300671MR5 00000300688MR9 00000300722MR6 00000300723MR4 00000300794MR5 00000300847MR1 00000300866MR1 00000300867MR9 00000300898MR4 00000300900MR8 00000300930MR5 00000299684MR1 00000299685MR8 00000299825MR0 00000300796MR0 00000300298MR7 00000300865MR3 00000300591MR5 00000299261MR8 00000299341MR8 00000299464MR8 00000300589MR9 00000300966MR9 00000299686MR6 00000300037MR9 00000300297MR9
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of: AL, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, LA,ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WT, WY. and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CROAT IA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, REPUBLIC OF KOREA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUKEYand UNITED KINGDOM.
  • Descripción del producto
    GE Healthcare, Discovery MR450 || Product Usage: The Discovery MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical 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 MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and 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