Events

Retiro De Equipo (Recall) de WEB 1000 - PRE-CONFIGURED SERVER WITH SOFTWARE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AGFA HEALTHCARE CORPORATION.

¿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
    88280
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2007-06-29
  • 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
    Possible issue due to java 1.6 upgrade that could result in errors by inadvertently altering patient studies while working in the impax/web1000 service/admin tools area.

Device

WEB 1000 - PRE-CONFIGURED SERVER WITH SOFTWARE
  • Modelo / Serial
    Model Catalog: L7DOS L7DPU (Lot serial: ); Model Catalog: LZS5R LZS9Z LZTA4 (Lot serial: ); Model Catalog: LD5G0001 (Lot serial: ); Model Catalog: 60+00015204 (Lot serial: ); Model Catalog: 60+00015172 (Lot serial: ); Model Catalog: LD4YN001 (Lot serial: ); Model Catalog: 60+00014889 (Lot serial: ); Model Catalog: 60+00014825 (Lot serial: ); Model Catalog: 60+00014809 (Lot serial: ); Model Catalog: 60+00014539 (Lot serial: ); Model Catalog: 60+00012701 (Lot serial: ); Model Catalog: 60+00011069 (Lot serial: ); Model Catalog: 60+00010784 (Lot serial: ); Model Catalog: 60+00010197 (Lot serial: ); Model Catalog: 60+00009890 (Lot serial: ); Model Catalog: 60+00009832 (Lot serial: ); Model Catalog: 60+00006558 (Lot serial: ); Model Catalog: 60+00006557 (Lot serial: ); Model Catalog: 60+00006556 (Lot serial: ); Model Catalog: 60+00004927 (Lot serial: ); Model Catalog: 60+00003007 (Lot serial: ); Model Catalog: 60+00003006 (Lot serial: ); Model Catalog: LHZQN007 (Lot serial: ); Model Catalog: IMPAX MA3000 (Lot seri
  • Descripción del producto
    WEB 1000
  • Manufacturer
    AGFA HEALTHCARE CORPORATION

Manufacturer

AGFA HEALTHCARE CORPORATION
  • Dirección del fabricante
    GREENVILLE
  • Empresa matriz del fabricante (2017)
    Agfa-Gevaert NV
  • Source
    HC