Events

Retiro De Equipo (Recall) de Siemens Digital Linear Accelerators of type MEVATRON, ARTISTE , PRIMUS, ONCOR and ARTISTE

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 AG.

¿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
    17913
  • Fecha de inicio del evento
    2014-12-23
  • 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
    Manufacturer has received reports of one electric board (g41) located inside of the linac gantry showing signs of over heating. after a detailed analysis the root cause was found to be one of the components that belong to this board (head driver pcb). the manufacturer has redesigned the head driver pcb to further mitigate the risk of local over heating on the g41 motherboard. the present corrective action comprises the replacement of the head driver pcb on afected systems.
  • Acción
    Product to be modified

Device

Siemens Digital Linear Accelerators of type MEVATRON, ARTISTE , PRIMUS, ONCOR and ARTISTE
  • Modelo / Serial
    Model: 08139789, 05864472, 05857912, 07360717, 05857920, 04504200, 01940035, 05500371, 09822685, 09411588, 09822693, 08515520, 01940753, 01924500, 09401506, 09401407, 09401316, 10941746 and 09401654, Affected:
  • Manufacturer
    Siemens AG

Manufacturer

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