Events

Retiro De Equipo (Recall) de Siemens Ysio Max X-Ray system

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
    18427
  • Fecha de inicio del evento
    2015-04-24
  • 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
    Images might be lost and corresponding acquisitions have to be repeated under the following circumstances:, 1. during an image recovery process on systems with portable detectors (max wi-d, max mini) the connection of the portable detector is sporadically not re-established., 2. if either the "undo" button on the rad subtask card or the "previous series" button on the image subtask card are pressed during image readout., 3. sporadically, during an automatic or a manual ris update. this may cause the deletion of the currently used study and all acquired images within this study.
  • Acción
    Software to be upgraded

Device

Siemens Ysio Max X-Ray system
  • Modelo / Serial
    Model: , Affected: Version VE10E
  • Manufacturer
    Siemens AG

Manufacturer

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