Events

Retiro De Equipo (Recall) de Device Recall VERO

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
    73436
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1308-2016
  • Fecha de inicio del evento
    2016-03-07
  • Fecha de publicación del evento
    2016-03-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144310
  • 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
    In rare cases the vero/mhi-tm2000 operator console could set an incorrect gantry angle for the first beam of an imrt treatment if certain specific conditions are met. if gantry angle for the first beam of imrt is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.
  • Acción
    A Field Safety Notice dated March 2, 2016, was sent to all affected customers via e-mail on March 7, 2016. The Field Safety Notice informed users of the problem and provided a safe workaround until corrected software is available. The correction will be free of charge and a Customer Service Representative will contact all affected customers to schedule its installation. Customers with questions were advised to contact their Customer Service Representative.

Device

Device Recall VERO
  • Modelo / Serial
    Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including New York, Texas, Florida, and Ohio
  • Descripción del producto
    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator || MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
  • 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