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
    77741
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-05-16
  • 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
    Mckesson horizon medical(hmi) releases 4.5 up to 11.9 and mckesson radiology 12.0: potential for image loss due to discrepancies between the index of images expected by the application and the actual content of the folder storing the images.

Device

HORIZON MEDICAL IMAGING MANAGEMENT SYSTEM - MEDICAL IMAGING
  • Modelo / Serial
    Model Catalog: HMI 11.9 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 11.0 8 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 11.7 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 11.6 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 11.5.2 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 11.5.1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 11.5 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 11.0.7 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 11.0.6 FR EXP2 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 11.0.6 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 5.0 SERVICE PACK 8 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 5.0 SERVICE PACK 7 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 5.0 SERVICE PACK 6 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 5.0 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: HMI 4.6.1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: H
  • Descripción del producto
    MCKESSON HORIZON MEDICAL IMAGING (HMI)
  • Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY

Manufacturer

CHANGE HEALTHCARE CANADA COMPANY