Events

Retiro De Equipo (Recall) de ADVIA 2120I ANALYZER WITH AUTOSAMPLER WITH AUTO WASTE

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
    27339
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-08-15
  • 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
    Siemens healthcare diagnostics is conducting a recall for advia 2120/2120i hematology systems that are connected to avdia autoslide systems (smn 10286141 or smn 10286142). siemens has determined that if an autosampler rack jam error occurs during operation of an advia 2120/2120i connected to an advia autoslide it is possible that the next slide processed by the autoslide could be labeled with the wrong sample identification information.

Device

ADVIA 2120I ANALYZER WITH AUTOSAMPLER WITH AUTO WASTE
  • Modelo / Serial
    Model Catalog: 10361798 (Lot serial: IR05220942); Model Catalog: 10361798 (Lot serial: IR05230942); Model Catalog: 10361798 (Lot serial: IR03480920); Model Catalog: 10361798 (Lot serial: IR03160918); Model Catalog: 10361798 (Lot serial: IR24131206); Model Catalog: 10361798 (Lot serial: IR24141206); Model Catalog: 10361798 (Lot serial: IR07341021); Model Catalog: 10361798 (Lot serial: IR07361021); Model Catalog: 10361798 (Lot serial: IR05480947); Model Catalog: 10361798 (Lot serial: IR05470947); Model Catalog: 10316162 (Lot serial: IRL19450811); Model Catalog: 10316162 (Lot serial: IR07580542); Model Catalog: 10316162 (Lot serial: IR07600542); Model Catalog: 10316162 (Lot serial: IR20800902); Model Catalog: 10316162 (Lot serial: IR09590610); Model Catalog: 10316162 (Lot serial: IR09290607); Model Catalog: 10316162 (Lot serial: IR08740603)
  • Descripción del producto
    ADVIA 2120I ANALYZER WITH AUTOSAMPLER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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