Events

Retiro De Equipo (Recall) de GE PET Discovery 600 and Discovery 690 Nuclear Medicine 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
    16008
  • Fecha de inicio del evento
    2014-01-09
  • 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
    A software issue exists when using list mode replay, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection. reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction., this issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions., this issue may lead to image misinterpretation and/or inaccurate treatment decisions.
  • Acción
    Software to be upgraded

Device

GE PET Discovery 600 and Discovery 690 Nuclear Medicine System
  • Modelo / Serial
    Model: 600 & 690, Affected: , Software version: Software versions pet_mict_plus.44 and pet_velocity.53
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC