Events

Retiro De Equipo (Recall) de Siemens AXIOM Artis X-ray system, handswitch

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
    16855
  • Fecha de inicio del evento
    2014-06-18
  • 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
    There is a potential problem with axiom artis or artis zee system in connection with hand switch material number 3771750 operated at the patient table to release a x-ray image. the hand switch to release an x-ray image at the patient table is equipped with a cable extension inside the table. a problem may occur if the connection between cable connection and hand switch is contaminated with an extraordinary large amount of fluid. in a worst case situation, uncontrolled release of an x-ray image may happen. if this situation occurs, the system terminates uncontrolled x-ray after a short period.
  • Acción
    Product to be modified

Device

Siemens AXIOM Artis X-ray system, handswitch
  • Modelo / Serial
    Model: Model: 3771750, Affected:
  • Manufacturer
    Siemens AG

Manufacturer

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