Events

Retiro De Equipo (Recall) de Magnetom Spectra 3.0 T System (MRI 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-00023-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-15
  • 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-00023-1
  • 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
    Due to an isolated production issue, the body coil in the mri may possibly be fatigued after certain months of usage. this fatigue may potentially lead to the risk of overheating during delivery of rf energy due to underestimated specific absorption rate (sar) in extremely rare conditions for head, neck and shoulder examinations. siemens is not currently aware of any incidents related to this issue. however, the risk of overheating which may include tissue damage cannot be totally excluded, although the possibility of occurrence for serious injury is extremely low according to siemens' risk assessment.
  • Acción
    Users are advised to undertake extra precautions during head, neck and shoulder scans ie, to advise patients to immediately communicate uncomfortable heating sensations so that the scan can be stopped. Body coils will be replaced as soon as possible for the systems which have been identified as having a slight beginning of aging. For the remaining potentially affected systems, tune up measurements and QA checks will be performed by the end of February 2014 to readjust the system if required to eliminate any immediate risk. All potentially affected body coils will be replaced by the end of May 2014.

Device

Magnetom Spectra 3.0 T System (MRI system)
  • Modelo / Serial
    Magnetom Spectra 3.0 T System (MRI system)Catalogue number: 10655588Serial numbers: 56031, 56029, 56019 & 56017ARTG number: 154128
  • Manufacturer
    Siemens Ltd

Manufacturer

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