Events

Retiro De Equipo (Recall) de AXIOM ARTIS BA

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
    136703
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-06-06
  • 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
    The field action ax002/15/s was previously performed to protect the artis table against liquid entry at critical locations. however it was further identified that larger amounts of liquid can still enter the table. this may result in electric table movement failure. this corrective action will increase the protection against liquid entry into the artis table.

Device

AXIOM ARTIS BA
  • Modelo / Serial
    Model Catalog: 5904656 (Lot serial: N/A); Model Catalog: 7007755 (Lot serial: N/A); Model Catalog: 10094141 (Lot serial: N/A); Model Catalog: 7728392 (Lot serial: N/A); Model Catalog: 10094137 (Lot serial: N/A); Model Catalog: 7727717 (Lot serial: N/A); Model Catalog: 10094142 (Lot serial: N/A); Model Catalog: 5904649 (Lot serial: N/A); Model Catalog: 10094135 (Lot serial: N/A); Model Catalog: 7008605 (Lot serial: N/A); Model Catalog: 5904433 (Lot serial: N/A); Model Catalog: 59 17 054 (Lot serial: N/A); Model Catalog: 10848283 (Lot serial: N/A); Model Catalog: 10848282 (Lot serial: N/A); Model Catalog: 10848281 (Lot serial: N/A); Model Catalog: 10848280 (Lot serial: N/A); Model Catalog: 10848355 (Lot serial: N/A); Model Catalog: 10848354 (Lot serial: N/A); Model Catalog: 10848353 (Lot serial: N/A); Model Catalog: 5904441 (Lot serial: N/A); Model Catalog: 10280959 (Lot serial: N/A); Model Catalog: 7555357 (Lot serial: N/A); Model Catalog: 7412807 (Lot serial: N/A)
  • Descripción del producto
    AXIOM ARTIS BA;AXIOM ARTIS TA;ARTIS ZEE BIPLANE;ARTIS ZEE CEILING;AXIOM ARTIS DFC MAGNETIC NAVIGATION;ARTIS ZEE FLOOR MN;AXIOM ARTIS BC;ARTIS ZEE FLOOR;AXIOM ARTIS DTA;AXIOM ARTIS FC;AXIOM ARTIS DBC MAGNETIC NAVIGATION;ARTIS Q;ARTIS Q.ZEN;AXIOM ARTIS FA A
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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