Events

Retiro De Equipo (Recall) de IMMULITE 2000-2000 XPI INSTRUMENT

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
    63674
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-02-10
  • 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 correction for the immulite 2000/immulite 2000 xpi analyzer connected to a versacell system. there is a potential for incorrect results to be reported from processing of a sample tube if certain conditions occur on the immulite 2000/immulite 2000 xpi analyzer connected to a versacell system. this issue can only occur with versacell systems that are connected to immulite 2000/immulite 2000 xpi systems. this issue does not affect any other analyzer that interfaces with the versacell system. not every instance of a dropped tube will lead to incorrect results.

Device

IMMULITE 2000-2000 XPI INSTRUMENT
  • Modelo / Serial
    Model Catalog: 030002-33 (Lot serial: all connected to VersaCell); Model Catalog: 10373214 (Lot serial: all connected to VersaCell); Model Catalog: 030002-13 (Lot serial: all connected to VersaCell)
  • Descripción del producto
    IMMULITE 2000-2000 XPI INSTRUMENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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