Events

Retiro De Equipo (Recall) de Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, manufactured from 1996 - 2003: - Millennium VG - Millennium VG and Hawkeye- Discovery VH - VaricamAll Infinia nuclear medicine systems, manufactured from 2003 – 2014:- Infinia - Infinia and Hawkeye - Infinia and Hawkeye 4 All Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty Ltd.

¿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
    RC-2014-RN-01052-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-26
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01052-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Ge healthcare has recently performed field actions (tga ref.: rc-2013-rn-00629-1; rc-2013-rn-00679-1; rc-2013-rn-00695-1) on ge healthcare nuclear medicine system due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry . as part of this field action, ge healthcare is updating the preventative maintenance procedure and schedule and added an additional preventative maintenance check for loose fasteners on the nuclear medicine systems.
  • Acción
    GE Healthcare is advising the customers to ensure that the organization that services the equipment uses the latest version of the Service manual and the Preventative Maintenance procedure available on GE website (link provided in the customer letter)

Device

Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, ma...
  • Modelo / Serial
    Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, manufactured from 1996 - 2003: - Millennium VG - Millennium VG and Hawkeye- Discovery VH - VaricamAll Infinia nuclear medicine systems, manufactured from 2003 – 2014:- Infinia - Infinia and Hawkeye - Infinia and Hawkeye 4 All Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems.ARTG number: 200439
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd