Events

Retiro De Equipo (Recall) de AXIOM ARTIS DFC

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿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
    64866
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-09
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    For the below artis systems: -artis q systems with sw version vd11 and gigalix x-ray tubes -artis zee with sw versions vc21c vd11 and megalix cat+ x-ray tubes -axiom artis systems with sw version vb35e and megalix x-ray tubes the semi-automatic focus switch may in cases of a special type of defect in foci "small" and "micro" (if present) does not work as intended when pressing the footswitch multiple times. this special type of focus defect that causes the failure of the semi-automated focus switch becomes more likely as the service life of the x-ray tube increases.

Device

AXIOM ARTIS DFC
  • Modelo / Serial
    Model Catalog: 7412807 (Lot serial: ALL); Model Catalog: 7728392 (Lot serial: ALL); Model Catalog: 7555365 (Lot serial: ALL); Model Catalog: 10094142 (Lot serial: ALL); Model Catalog: 7008605 (Lot serial: ALL); Model Catalog: 10094135 (Lot serial: ALL); Model Catalog: 10094139 (Lot serial: ALL); Model Catalog: 10094137 (Lot serial: ALL); Model Catalog: 7555357 (Lot serial: ALL); Model Catalog: 10280959 (Lot serial: ALL); Model Catalog: 10848353 (Lot serial: ALL); Model Catalog: 10094141 (Lot serial: ALL); Model Catalog: 10848280 (Lot serial: ALL); Model Catalog: 10848281 (Lot serial: ALL); Model Catalog: 10848282 (Lot serial: ALL); Model Catalog: 10848283 (Lot serial: ALL); Model Catalog: 10848355 (Lot serial: ALL)
  • Descripción del producto
    AXIOM ARTIS DFC;AXIOM ARTIS DBC;AXIOM ARTIS DMP;AXIOM ARTIS ZEE FLOOR MN;AXIOM ARTIS DTA;ARTIS ZEE FLOOR;ARTIS ZEE MULTI-PURPOSE;ARTIS ZEE CEILING;AXIOM ARTIS DBA;ARTIS ZEEGO MULTI-AXIS;ARTIS Q.ZEN;ARTIS ZEE BIPLANE;ARTIS Q
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC