Events

Retiro De Equipo (Recall) de MHITM2000 Linear Accelerator System

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 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK.

¿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
    70638
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1574-2015
  • Fecha de inicio del evento
    2015-04-17
  • Fecha de publicación del evento
    2015-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135485
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. in addition, the treatment record (the delivered radiation record) cannot be saved.
  • Acción
    MITSUBISHI HEAVY INDUSTRIES, LTD. has issued a Safety Alert for the MHI-TM2000 Linear Accelerator System dated April 10, 2015, due to a software issue. Customers were advised not to deliver therapeutic X-ray if popup warning message show is displayed during treatment. Instructions were provided if therapeutic radiation is delivered during popup warning. Customers with questions should contact the Customer Service Representative by calling 1-800-597-5911, Monday through Friday or email: us.support@brainlab.com. **CAPA** Correction software for this issue has a tentative availability date of June 2015. Estimated software update completion date would be end of October 2015.

Device

MHITM2000 Linear Accelerator System
  • Modelo / Serial
    Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
  • Descripción del producto
    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
  • Manufacturer
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Manufacturer

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
  • Dirección del fabricante
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA Japan
  • Empresa matriz del fabricante (2017)
    Mitsubishi Heavy Industries Ltd.
  • Source
    USFDA