Events

Retiro De Equipo (Recall) de ULTRA-SOUND SCOPE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PENTAX 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
    16449
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-06-23
  • 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
    Pentax medical has been notified of a potential risk related to the use of certain models of ultrasound gastroscope listed above in combination with aspiration needles if the instructions for use document is not followed carefully by the user. specifically if the user fails to properly position the elevator while advancing the aspiration needles through the endoscope then the needle can derail from the elevator. this could result in the needles not being visible in the endoscopic or sonographic field of view leaving to the possibility of patient injury such as perforation.

Device

ULTRA-SOUND SCOPE
  • Modelo / Serial
    Model Catalog: EG-3870UTK (Lot serial: A110260); Model Catalog: FG-36UX (Lot serial: E110164); Model Catalog: EG-3630U (Lot serial: E110164); Model Catalog: EG-3830UT (Lot serial: E110164); Model Catalog: EG-3870UTK (Lot serial: E110164); Model Catalog: FG-36UX (Lot serial: A110308); Model Catalog: EG-3630U (Lot serial: A110308); Model Catalog: EG-3830UT (Lot serial: A110308); Model Catalog: EG-3870UTK (Lot serial: A110308); Model Catalog: FG-36UX (Lot serial: E110332); Model Catalog: EG-3630U (Lot serial: E110332); Model Catalog: EG-3830UT (Lot serial: E110332); Model Catalog: EG-3870UTK (Lot serial: E110332); Model Catalog: FG-36UX (Lot serial: A110247); Model Catalog: EG-3630U (Lot serial: A110247); Model Catalog: EG-3830UT (Lot serial: A110247); Model Catalog: EG-3870UTK (Lot serial: A110247); Model Catalog: FG-36UX (Lot serial: A110468); Model Catalog: EG-3630U (Lot serial: A110468); Model Catalog: EG-3830UT (Lot serial: A110468); Model Catalog: EG-3870UTK (Lot serial: A110468); Model Catalog: FG-36UX (
  • Descripción del producto
    ULTRASOUND GASTROSCOPES
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

PENTAX CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    HC