Events

Retiro De Equipo (Recall) de CENTRICITY UNIVERSAL VIEWER - MAIN UNIT

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

¿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
    130524
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-02-06
  • 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
    The following issue is being addressed by ge healthcare file no. fmi 85442. ge healthcare has recently become aware that a database handling error could occur during the image acquisition process affecting the completeness of acquired images with centricity universal viewer running on a pacs-iw foundation. there is a potential that one or more "image series" (i.E. all images within an image set) may be missing from an exam without a user warning displayed in the viewer. while this is rare this can occur with imaging studies that consist of a very small number of images per series. e.G. cr thorax exam with 1 image per series. there have been no injuries reported as a result of this issue.

Device

CENTRICITY UNIVERSAL VIEWER - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 2088034-X (Lot serial: GTIN 00840682103800)
  • Descripción del producto
    CENTRICITY UNIVERSAL VIEWER - MAIN UNIT
  • Manufacturer
    GE HEALTHCARE CANADA INC.

Manufacturer

GE HEALTHCARE CANADA INC.