Events

Retiro De Equipo (Recall) de Device Recall GE SIGNA Pioneer

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 Medical Systems, 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
    73555
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1347-2016
  • Fecha de inicio del evento
    2016-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144455
  • 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
    Ferrous material in the signa pioneer table control box (tcb) could cause unexpected attraction to the mr system's high strength magnetic field during servicing activities. this could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the tcb from the magnetic field. there have been no events reported as a result of this issue. clinical scanni.
  • Acción
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 68002 dated March 1, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions or concerns regarding this notification,contact GE Healthcare Service at 18004371171 or your local Service Representative.

Device

Device Recall GE SIGNA Pioneer
  • Modelo / Serial
    Mfg Lot or Serial # System ID  001612TA1 N/A 001718TA6 336397P3T  002331TA7 083132425984 001719TA4 250598MR1 001424TA1 M2850013 001537TA0 TP0008MR07 001662TA6 157022MR01 001184TA1 ZC0002 001652TA7 N/A 002227TA7 ZC0003 002278TA0 ZC0004 002330TA9 ZC0006 002529TA6 N/A 001485TA2 34026MRS05 002279TA8 34225MRS02 002395TA2 34185MRS02
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of SC, NC and the countries of Australia, Canada, France. Germany, Japan and Turkey.
  • Descripción del producto
    SIGNA Pioneer MR Systems || Product Usage: || The SIGNA Pioneer 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 SIGNA Pioneer 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 Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Dirección del fabricante
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA