Events

Retiro De Equipo (Recall) de Device Recall MiroCam Capsule Endoscope Syste

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por IntroMedic Co., Ltd..

¿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
    79830
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1615-2018
  • Fecha de inicio del evento
    2017-02-15
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163624
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, imaging, gastrointestinal, wireless, capsule - Product Code NEZ
  • Causa
    When a user switches on mr1100 receiver, even though the battery was fully charged, the led was displayed as orange color due to momentary drop of battery voltage.
  • Acción
    Intromedic representatives visited hospitals with the affected products after the first awareness of the problem in order to explain the corresponding issue to our distributor in USA and gave them training on how to check the software before and after the software update. Firm revisited the hospitals in which the software was not conducted by our distributor and carried out the software update since Nov 13th, 2017. The software update was not made immediately as we believe that the reoccurrence possibility of this issue is very low since have not received any other report of the issue from USA and other countries, and the receiver works fine after it is turned off and on again. Some of the hospitals visited refused to conduct software update while being aware of the issue as they were not encountered with the issue. The remaining hospitals in which software update is not conducted will be visited and software update will be conducted by firm's distributor by April.

Device

Device Recall MiroCam Capsule Endoscope Syste
  • Modelo / Serial
    None
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC
  • Descripción del producto
    Miriam Capsule Endoscope System. Model MR1100 || Product Usage: || MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
  • Manufacturer
    IntroMedic Co., Ltd.

Manufacturer

IntroMedic Co., Ltd.
  • Dirección del fabricante
    IntroMedic Co., Ltd., F-Rtek 6 Floor, 11-25 Simindaero327beon-Gil; Dongan, Anyang Korea (the Republic of)
  • Empresa matriz del fabricante (2017)
    IntroMedic Co., Ltd.
  • Source
    USFDA