Events

Retiro De Equipo (Recall) de LIGHTSHEER DESIRE LASER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CLARION MEDICAL 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
    135923
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-03-13
  • 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
    A discrepancy in subject device product labeling exists. the programmed software settings were determined to be higher than those required for the model of handpiece deployed on patients. an examination of subject device lightsheer desire laser system labeling found the physician recommended treatment settings did not match the settings identified by the subject device software when specific patient skin types and hair color were selected. an inexperienced device operator would not be aware the treatment settings identified by the system software are incorrect.

Device

LIGHTSHEER DESIRE LASER
  • Modelo / Serial
    Model Catalog: LIGHTSHEER DESIRE (Lot serial: >10 contact mfg.)
  • Descripción del producto
    Lightsheer desire laser
  • Manufacturer
    CLARION MEDICAL TECHNOLOGIES INC.

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.