Events

Retiro De Equipo (Recall) de ARTIS ZEE CEILING

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
    32427
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-10-02
  • 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
    A particular component may not have been fitted correctly during the installation of some mavig portegra 2 systems (a ceiling suspension system). the component in question is not actively involved in the operation of the mavig portegra 2 system and its absense does not have an adverse effect on system function. the component would hold a pin in position in case that pin gets released and thus prevent system parts from becoming loose leading to an adverse effect on the function and possibly becoming detached from the system.

Device

ARTIS ZEE CEILING
  • Modelo / Serial
    Model Catalog: 10094137 (Lot serial: ); Model Catalog: 7727717 (Lot serial: ); Model Catalog: 10094139 (Lot serial: ); Model Catalog: 7555365 (Lot serial: ); Model Catalog: 10094135 (Lot serial: ); Model Catalog: 7412807 (Lot serial: ); Model Catalog: 7728392 (Lot serial: ); Model Catalog: 7008605 (Lot serial: ); Model Catalog: 10280959 (Lot serial: ); Model Catalog: 59 17 054 (Lot serial: ); Model Catalog: 10094141 (Lot serial: ); Model Catalog: 7555357 (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    ARTIS ZEE CEILING
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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