Events

Retiro De Equipo (Recall) de Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging 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 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-01113-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-23
  • 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-01113-1
  • 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 has received reports of unintended radial motion of the detectors. this unintended motionmay cause the patient, compression related injuries. the symbia s or t system has been designed to detect such faults and automatically shut down. if the system shuts down with the message "system requires service, please contact your customer service representative" the system will be disabled until the error is manually cleared during service there have been no reports of injury as a result of this potential motion.
  • Acción
    A Siemens local service engineer will contact customers to perform the inspection and schedule any necessary repairs to the affected systems. Siemens is advising that while waiting for the inspection to be performed, customers can continue to use their systems by adhering to the Cautions and Warnings in the user's manual and observing the patients during studies. This action has been closed-out on 08/08/2016.

Device

Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system)
  • Modelo / Serial
    Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system)Catalogue numbers: 8717733, 8717741, 10275007, 10275008, 10275009 & 10275010ARTG numbers: 123883 & 186317
  • Manufacturer
    Siemens Ltd

Manufacturer

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