Events

Retiro De Equipo (Recall) de Symbia E and e.cam collimator (nuclear imaging gamma camera system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-00330-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-21
  • 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-00330-1
  • 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
    Siemens have received complaints regarding incidents where collimator change activities have resulted in operator injury. the investigation found that these incidents may have been avoided by operators properly following specified instructions. the system was designed to safely store and exchange collimators, however if the instructions are not followed serious injuries, such as broken bones and lacerations, may occur. siemens have determined that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasise the proper collimator change process.
  • Acción
    Siemens is providing users with addendum instructions to follow during collimator change activities. This action has been closed-out on 27/01/2017.

Device

Symbia E and e.cam collimator (nuclear imaging gamma camera system)
  • Modelo / Serial
    Symbia E and e.cam collimator (nuclear imaging gamma camera system)Catalogue Numbers: 10275879, 10413009, 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823920, 07823938, 07823946, 07823953, 07823961, 07823979, 10151531, 10151532, 10520745ARTG Number: 186317
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA