Events

Retiro De Equipo (Recall) de 3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures)

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-2016-RN-00176-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-15
  • 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-2016-RN-00176-1
  • 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 become aware of a potential safety issue with the 3.0t gemflex coil manufactured by neocoil used with ge healthcare 3.0t scanners. part of the cable assembly may overheat when the device is used. there is a rare probability that this could result in minor burn injury in case of prolonged direct skin contact with the overheating part. so far there have been no injuries reported as a result of this issue.
  • Acción
    GE Healthcare is advising users to ensure the user instructions are followed in regards to using proper padding to avoid all direct contact of the patient with the cable. The device can continue to be used while GE are implementing a permanent correction. This action has been closed-out on 23/05/2017.

Device

3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses f...
  • Modelo / Serial
    3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures)Affected Products:3.0T GEM Flex Coil 16-L Array 5430008-23.0T GEM Flex Coil 16-M Array 5430008-33.0T GEM Flex Coil 16-S Array 5430008-43.0T GEM Flex Interface 5430008-5ARTG Number: 153134
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd