Events

Retiro De Equipo (Recall) de INSTRUMENT MANAGER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    23543
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-03-08
  • 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
    Importing error code mapping into instrument manager (im) v.8.12.10 and higher may clear another configuration's error code mapping. results that should be flagged from that configuration will not be flagged and have no result error codes. rules that evaluate error code(s) may also be affected. per data innovations: the absence of result flags and error codes compromises result evaluation and handling. medical decisions based on these potentially erroneous results can lead to patient harm.

Device

INSTRUMENT MANAGER
  • Modelo / Serial
    Model Catalog: VX.XX (Lot serial: software-no lot numbers); Model Catalog: 8.14.01 (Lot serial: software-no lot numbers); Model Catalog: 8.14.00 (Lot serial: software-no lot numbers); Model Catalog: 8.13.04 (Lot serial: software-no lot numbers); Model Catalog: 8.13.03 (Lot serial: software-no lot numbers); Model Catalog: 8.13.02 (Lot serial: software-no lot numbers); Model Catalog: 8.13.01 (Lot serial: software-no lot numbers); Model Catalog: 8.13.00 (Lot serial: software-no lot numbers); Model Catalog: 8.12.22 (Lot serial: software-no lot numbers); Model Catalog: 8.12.21 (Lot serial: software-no lot numbers); Model Catalog: 8.12.20 (Lot serial: software-no lot numbers); Model Catalog: 8.12.12 (Lot serial: software-no lot numbers); Model Catalog: 8.12.11 (Lot serial: software-no lot numbers); Model Catalog: 8.12.10 (Lot serial: software-no lot numbers); Model Catalog: VX.XX (Lot serial: N/A); Model Catalog: 8.14.01 (Lot serial: N/A); Model Catalog: 8.14.00 (Lot serial: N/A); Model Catalog: 8.13.04 (Lot seria
  • Descripción del producto
    DATA INNOVATIONS INSTRUMENT MANAGER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC