Events

Retiro De Equipo (Recall) de KT-DTM LAMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por KLOX TECHNOLOGIES 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
    25272
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-04-22
  • 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
    This information is initiated as a result of an investigation following the development of a new kt-d design in which the power density of the new design did not yield the same results made by two different testing facilities and with controlled and transfered methods. a detailed investigation has confirmed that there were issues related to the power density method its transfer and its validation. it is posible that the power density of the kt-d lamp may have a higher value than the value currently approved in production established at 55.6 to 71.6 mw/cm2.

Device

KT-DTM LAMP
  • Modelo / Serial
    Model Catalog: KLLA0405-01 (Lot serial: More than 10 contact manuf.); Model Catalog: KLLA0305-01 (Lot serial: More than 10 contact manuf.)
  • Descripción del producto
    KT-DTM LAMP
  • Manufacturer
    KLOX TECHNOLOGIES INC.

Manufacturer

KLOX TECHNOLOGIES INC.