Events

Retiro De Equipo (Recall) de Siemens Mammomat Fusion/Inspiration

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens Healthcare GmbH.

¿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
    21016
  • Fecha de inicio del evento
    2017-01-16
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    The manufacturer has become aware of potential errors that may occur while performing a biopsy. the system may freeze and the biopsy functionality may become not available in the following situations:, a) drop of the compression force, e.G. this may occur due to a patient sudden movement during the active targeting phase., b) or use of the inversion tool while the scout image is active during the targeting phase.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens Mammomat Fusion/Inspiration
  • Modelo / Serial
    Model: , Affected: 10140000 with software version VB30 and with a Biopsy option
  • Manufacturer
    Siemens Healthcare GmbH

Manufacturer

Siemens Healthcare GmbH
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA