Events

Retiro De Equipo (Recall) de OCTOPUS 900 PRO

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INNOVA MEDICAL OPHTHALMICS 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
    51949
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-11-08
  • 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
    Due to a software error the background illumination of the cupola may not be switched on at the start of an examination. results will appear to be "better" than the actual ones. due to the software error an examination taken with the dynamic or normal strategy may show a huge overshoot in the cumulated defect (bebie) curve and the corresponding visual field indices (md and ms). the effect is less obvious with the top strategy. if these results are considered in isolation from the results of previous visual field examinations or from other examinations (e.G. intraocular pressure measurements or examinations of the optic nerve head) the visual field of the patient may remain untreated.

Device

OCTOPUS 900 PRO
  • Modelo / Serial
    Model Catalog: 7220002 (Lot serial: VARIOUS LOTS); Model Catalog: 7220001 (Lot serial: VARIOUS LOTS)
  • Descripción del producto
    OCTOPUS 900 PRO
  • Manufacturer
    INNOVA MEDICAL OPHTHALMICS INC.

Manufacturer

INNOVA MEDICAL OPHTHALMICS INC.