Events

Retiro De Equipo (Recall) de OPTIMA MR450W MRI SYSTEM - MAIN UNIT - GEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    27248
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-04
  • 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
    Devices may generate non-unique series identifiers which when exported to some pacs systems results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. the issue may result in an incorrect diagnosis from the study with mixed patient data if the series protocol and anatomy on the studies are similar and the annotation is not noticed. the conditions under which the issue is known to be possible require that the studies have identical time of day and that the exams be on an affected model of pacs at the same time.

Device

OPTIMA MR450W MRI SYSTEM - MAIN UNIT - GEM
  • Modelo / Serial
    Model Catalog: M7000ZJ (Lot serial: N/A); Model Catalog: M7000BB (Lot serial: N/A); Model Catalog: M7000WB (Lot serial: N/A); Model Catalog: M7000WA (Lot serial: N/A); Model Catalog: M7000BH (Lot serial: N/A); Model Catalog: M7000WC (Lot serial: N/A)
  • Descripción del producto
    OPTIMA MR450W MRI SYSTEM - GEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)