Events

Retiro De Equipo (Recall) de HORIZON MEDICAL IMAGING MANAGEMENT SYSTEM - MEDICAL IMAGING

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

¿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
    79261
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-05-30
  • 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
    When two or more processes attempt to modify the same image folder within fractions of a second the write lock mechanism may fail to prevent concurrent modification of the same data. this may result in data loss within the image folder.

Device

HORIZON MEDICAL IMAGING MANAGEMENT SYSTEM - MEDICAL IMAGING
  • Modelo / Serial
    Model Catalog: HMI 11.0.8 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.5.2 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.6 FR EXP2 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.6 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.5 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.4 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.3 (Lot serial: >10. contact mfg); Model Catalog: MR 12.0 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.9 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.8 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.7 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.6 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.5 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0 (Lot serial: >10. contact mfg); Model Catalog: HMI 5 (Lot serial: >10. contact mfg); Model Catalog: HMI 4.6.1 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.0.7 (Lot serial: >10. contact mfg); Model Catalog: HMI 11.5.1 (Lot serial: >10. contac
  • Descripción del producto
    Horizon Medical Imaging Management System
  • Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY

Manufacturer

CHANGE HEALTHCARE CANADA COMPANY