Events

Retiro De Equipo (Recall) de INTELEPACS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INTELERAD MEDICAL SYSTEMS INCORPORATED.

¿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
    139011
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-11-30
  • 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
    Following a complaint from a client intelerad is taking a pro-active field action to prevent occurrence of a possible patient safety problem at client sites. the issue is triggered by the presence of the "less than" character (<) in the report. when viewing a report the "less than" character is not present while it was there in the original report received by intelepacs. in other cases when the character is present in a combination with other characters parts of the report text following the less than character are not displayed depending on the intelerad application used by the end-user to review the reports.

Device

INTELEPACS

Manufacturer

INTELERAD MEDICAL SYSTEMS INCORPORATED