Events

Retiro De Equipo (Recall) de Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B and VC40A

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-2018-RN-00183-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-27
  • 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-2018-RN-00183-1
  • 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 healthcare became aware of possible incorrect tube current calculations by the care dose4d algorithm for scans that include the head, when based only on p.A. (posterior-anterior) or a.P. topograms. depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dosedistribution is not appropriate and could lead to unnecessary radiation exposure. the described issue will not occur when using a lateral topogram instead of a p.A. or an a.P. topogram. there have been no injuries reported as a result of this issue.
  • Acción
    Siemens is strongly recommending using lateral topograms for all head scans. Considering that the p.a. or a.p. topogram is preferred in specific protocols such as in CarotidAngio scans and RT_ HeadNeckShoulder, it is strongly recommended to deactivate the CARE Dose4D function for this type of scan. For software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B, VC40A, to prevent any possible deterministic radiation effects on the patient's skin or eye lenses, Siemens Healthcare implemented a dose alert according to the technical standard IEC 60601-2-44. A warning will be shown and has to be confirmed by the user if the accumulated CTDIvol for the ongoing examination exceeds the alert threshold in any z-position. The default setting for the threshold is adjusted to 1000 mGy.

Device

Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B...
  • Modelo / Serial
    Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B and VC40AARTG Numbers: 142119 and 274034(Siemens Healthcare - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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