Events

Retiro De Equipo (Recall) de ADVIA 1200 CHEMISTRY SYSTEM - INSTRUMENT CLASS 2

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
    76746
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-12-19
  • 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
    In the advia 1200 chemistry system (software versions v2.00 and v2.01) and advia 1650 chemistry system (software versions v3.52 and v4.01) an overflow flag ///// is displayed in the result column for a test when the algorithm for that test cannot calculate a result or when the concentration of a test cannot be determined because it is outside the absorbance limits. ///// is not a usable or reportable result however it is possible for the user to misinterpret or edit this result.

Device

ADVIA 1200 CHEMISTRY SYSTEM - INSTRUMENT CLASS 2
  • Modelo / Serial
    Model Catalog: 094-A002-01 (Lot serial: CA12250023); Model Catalog: 02475632 (Lot serial: CA12250023); Model Catalog: M094-A002-01 (Lot serial: CA12250023); Model Catalog: 10309735 (Lot serial: CA12260020); Model Catalog: 094-A002-01 (Lot serial: CA12260020); Model Catalog: 02475632 (Lot serial: CA12260020); Model Catalog: M094-A002-01 (Lot serial: CA12260020); Model Catalog: 10309735 (Lot serial: CA12260019); Model Catalog: 094-A002-01 (Lot serial: CA12260019); Model Catalog: 02475632 (Lot serial: CA12260019); Model Catalog: M094-A002-01 (Lot serial: CA12260019); Model Catalog: 10309735 (Lot serial: CA12240082); Model Catalog: 094-A002-01 (Lot serial: CA12240082); Model Catalog: 02475632 (Lot serial: CA12240082); Model Catalog: M094-A002-01 (Lot serial: CA12240082); Model Catalog: 10309735 (Lot serial: CA12250088); Model Catalog: 094-A002-01 (Lot serial: CA12250088); Model Catalog: 02475632 (Lot serial: CA12250088); Model Catalog: M094-A002-01 (Lot serial: CA12250088); Model Catalog: 094-A002-01 (Lot serial
  • Descripción del producto
    ADVIA 1200 CHEMISTRY SYSTEM INSTRUMENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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