Events

Retiro De Equipo (Recall) de Symbia T Series and Symbia Intevo Camera System (SPECT/CT 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-00881-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-08
  • 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-00881-1
  • 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 recently detected a rubber isolator with unfavourable aging properties. the function of this rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. in rare cases, when unfavourable aging has occurred, the rubber isolator may break and cause loss of support for the rotate motor. this event could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient. the possibility of a serious injury does exist if the belt makes contact with the patient. siemens have not received any reports of injury with the symbia t or symbia lntevo camera systems as a result of this problem.
  • Acción
    Customers are advised that they can continue to use the systems while waiting for the corrective action to be undertaken which includes new mounting plate with improved rubber components and a backup device to ensure trouble free operation in the future. If users are experiencing abnormal noise or vibration, they are advised to immediately discontinue use and asked to contact their service engineer. Users are also asked to ensure that the safety advisory is placed in the System Owner's Manual. This action has been closed-out on 15/07/2016.

Device

Symbia T Series and Symbia Intevo Camera System (SPECT/CT diagnostic imaging system)
  • Modelo / Serial
    Symbia T Series and Symbia Intevo Camera System (SPECT/CT diagnostic imaging system)Multiple catalogue numbers affectedARTG Number: 123883
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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