Events

Retiro De Equipo (Recall) de SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body computed tomography (CT) diagnostic x-ray 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-00457-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-17
  • 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-00457-1
  • 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
    The mechanical function of the rubber damper, which is situated within the mounting assembly of the rotation motor, may potentially degrade over time and may impact stability. in rare cases, the rubber damper may break and cause the loosening of the mounting plates in the gantry. this event is not posing a hazard by itself but could lead to a rupture of the drive belt and subsequently to a scan abort. additionally the broken belt may damage the system cover so that the contact protection against rotating parts inside the gantry can’t be granted for the operator and patient.
  • Acción
    Siemens is advising that there is no workaround for the user to minimise the potential risk of this issue. Siemens has developed a modification for the affected systems which is to replace the rotation motor mounting plate inside the gantry of the CT system by a new model. This new mounting plate includes significantly improved rubber dampers for the stability of the assembly. This action has been closed-out on 12/02/2016.

Device

SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body com...
  • Modelo / Serial
    SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body computed tomography (CT) diagnostic x-ray system)Catalogue numbers: 10045692, 10165566, 10165888, 10165977, 10415118, 10415119, 10415116 & 10415117ARTG number: 142119
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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