Events

Retiro De Equipo (Recall) de NDI DISPOSABLE REFLECTIVE MARKER SPHERE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por NORTHERN DIGITAL 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
    20776
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-07-21
  • 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
    On april 30 2015 ndi received a complaint from a customer reporting that a drms sphere fell apart while the patient's leg was being aligned with the navigation system during a total knee replacement surgery... based on the reported complaint ndi promptly instituted a stop ship order... then performed a recall of the affected lot... further investigation has identified a similar failure mode with different root causes that has occurred at a significantly lower rate in additional lots of the product.

Device

NDI DISPOSABLE REFLECTIVE MARKER SPHERE
  • Modelo / Serial
    Model Catalog: 41773 (Lot serial: C106861402); Model Catalog: 41773 (Lot serial: C103091402); Model Catalog: 41773 (Lot serial: C102811402); Model Catalog: 41773 (Lot serial: C100641501); Model Catalog: 41773 (Lot serial: C101791401); Model Catalog: 41773 (Lot serial: C101021501); Model Catalog: 41773 (Lot serial: C100641502); Model Catalog: 41773 (Lot serial: C102581402)
  • Descripción del producto
    NDI DISPOSABLE REFLECTIVE MARKER SPHERE
  • Manufacturer
    NORTHERN DIGITAL INC.

Manufacturer

NORTHERN DIGITAL INC.