Retiro De Equipo (Recall) de Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 become aware of a potential safety issue due to a collimator installation error during a service maintenance activity. if a device is improperly re-installed, the collimator may not be properly seated and may loosen and fall. such an event may occur immediately following re-installation during a servicemaintenance activity, but may also occur a few months after a service activity and continued use. a fall of a collimator while the system is in use could result in an injury to a patient or operator. there was a reported incident of a collimator fall which caused a serious patient injury.
  • Acción
    GE is advising customers that if they observe any abnormal collimator movement, immediately stop using the system and contact their local GE Healthcare Service Representative. During planned maintenance, customers are also advised not to perform the demounting and re-mounting of collimator for Proteus XR/a and Revolution XR/d X-ray imaging systems as stated in the manuals. A GE Healthcare service representative will contact customers to verify that all affected systems are properly installed and to implement correction if necessary.


  • Modelo / Serial
    Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systemsProteus XR/a X-ray imaging systems installed with collimator part numbers 2261763 and 2261765 ARTG 98099 All Revolution XR/d X-ray imaging systemsARTG 114083
  • Manufacturer