Events

Retiro De Equipo (Recall) de GE Signa Magnetic Resonance Imaging System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand 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
    14656
  • Fecha de inicio del evento
    2013-05-16
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    For clariview and screen save from gvtk (gems visualization toolkit) viewer, the mr product can generate image headers with non-unique series identifiers, which when exported to some pacs systems, results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. in all cases, patient identifying annotation remains correct.
  • Acción
    Software to be upgraded

Device

GE Signa Magnetic Resonance Imaging System
  • Modelo / Serial
    Model: Models: 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, Affected: PACS systems manufactured by Intelerad (IntelePACS 4-3-1-P350 and InteleBrowser -4-3-1-P350)
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC