Events

Retiro De Equipo (Recall) de Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, manufactured from 2003-2013VG and VG Hawkeye nuclear medicine systems, manufactured from 1996-2003 Helix nuclear medicine systems, manufactured from 1992-1996 (by Elscint Ltd)

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-2013-RN-00629-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-20
  • 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-2013-RN-00629-1
  • 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 (hc) has recently became aware of an incident in the united states, a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 where the equipment fell onto the patient during the scan. gehc was permitted access to the equipment on 17 june 2013 and investigation is ongoing. as a result, gehc has not been able to determine the root cause of this incident.
  • Acción
    GE Healthcare recommends that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to the schedule provided in customer documentation. Customers are asked to review safety chapter sections with appropriate personnel to ensure proper operation of the equipment. GE Healthcare is working in conjunction with the TGA for a complete investigation into the incident and will undertake any further action if required.

Device

Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, ma...
  • Modelo / Serial
    Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, manufactured from 2003-2013VG and VG Hawkeye nuclear medicine systems, manufactured from 1996-2003Helix nuclear medicine systems, manufactured from 1992-1996 (by Elscint Ltd)Multiple products affectedARTG number: 200439
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd