Events

Retiro De Equipo (Recall) de AXIOM ARTIS FA ALPHA

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
    117057
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-09-14
  • 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
    It was identified that there is potential that a possible position sensor fault in the swivel base axis is not being detected by the system software. following the enabling of movement by the operator the c-arm system can unexpectedly move faster than normal. please note that the system will not move without movement being initiated by the operator however the speed at which it can move would be faster than normal.

Device

AXIOM ARTIS FA ALPHA
  • Modelo / Serial
    Model Catalog: 5904441 (Lot serial: ); Model Catalog: 5904656 (Lot serial: ); Model Catalog: 5904466 (Lot serial: ); Model Catalog: 7555357 (Lot serial: (FOR ALL DEVICES)); Model Catalog: 7555357 (Lot serial: VERSION VB23N OR VB35E); Model Catalog: 7555357 (Lot serial: SERIAL #S RUNNING SOFTWARE); Model Catalog: 5904649 (Lot serial: ); Model Catalog: 7412807 (Lot serial: ); Model Catalog: 7555365 (Lot serial: ); Model Catalog: 59 17 054 (Lot serial: ); Model Catalog: 59 04 433 (Lot serial: ); Model Catalog: 7728392 (Lot serial: ); Model Catalog: 7727717 (Lot serial: ); Model Catalog: 7555357 (Lot serial: THE AFFECTED SYSTEMS COVER ALL)
  • Descripción del producto
    AXIOM ARTIS FA ALPHA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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