Events

Retiro De Equipo (Recall) de ARTAIS ZEE BIPLANE MN

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
    19495
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-12-11
  • 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 artis systems in conjunction with the artis table: the artis table top carriage is mounted on top of the table base and fixed with a bolt. a snap ring is used to secure the bolt. in rare cases it was identified that the snap ring is not properly fixed. in case of a missing or wrongly installed snap ring the bolt could slide out of its base and the table top carriage could slide to the floor.

Device

ARTAIS ZEE BIPLANE MN
  • Modelo / Serial
    Model Catalog: 10094143 (Lot serial: N/A); Model Catalog: 5904656 (Lot serial: N/A); Model Catalog: 7007755 (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: 10094141 (Lot serial: N/A); Model Catalog: 7728392 (Lot serial: N/A); Model Catalog: 10280959 (Lot serial: N/A); Model Catalog: 10094135 (Lot serial: N/A); Model Catalog: 7412807 (Lot serial: N/A); Model Catalog: 5904466 (Lot serial: N/A); Model Catalog: 7555357 (Lot serial: N/A); Model Catalog: 7555373 (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: 59 17 054 (Lot serial: N/A); Model Catalog: 5904433 (Lot serial: N/A); Model Catalog: 7008605 (Lot serial: N/A); Model Catalog: 5904649 (Lot serial: N/A); Model Catalog: 10094137 (Lot serial: N/A); M
  • Descripción del producto
    ARTAIS ZEE BIPLANE MN;AXIOM ARTIS BA;AXIOM ARTIS TA;ARTIS Q;AXIOM ARTIS DBC;ARTIS ZEEGO MULTI-AXIS;AXIOM ARTIS DFC;AXIOM ARTIS MP DIAGNOSTIC;AXIOM ARTIS DBA;AXIOM ARTIS DFA;ARTIS Q.ZEN;AXIOM ARTIS FA ALPHA;AXIOM ARTIS DBC MAGNETIC NAVIGATION;AXIOM ARTIS F
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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