Events

Retiro De Equipo (Recall) de Device Recall MHITM2000/ VERO (TM)

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
    65786
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1931-2013
  • Fecha de inicio del evento
    2013-06-21
  • Fecha de publicación del evento
    2013-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120158
  • 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
    Software anomaly: mitsubishi heavy industries, ltd. became aware of a potential safety issue associated with the vero (tm) linear accelerator system. the vero (tm) may save treatment delivery record into wrong location under certain conditions.
  • Acción
    The firm, Mitsubishi Heavy Industries, Ltd. (MHI), sent an "URGENT FIELD SAFETY NOTICE" letter dated June 21, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: If any minor failure occurs, please always press [ALARM RESET] button on operator console first; and if [EXIT] button is clicked after a minor failure occurs, please click [YES] on the pop up dialog to finish treatment completely. MHI is developing a correction for this issue. Tentatively planned availability date: End of October 2013. The correction will be free of charge and a MHI Customer Service representative will contact affected customers to schedule its installation as the correction becomes available. If you need any further information or support concerning this issue, please feel free to contact our Customer Service representative: VERO GmbH, Kapellenstrasse 12, 8566 Feldkirchen Germany, at +49-89-99-1568-44 or email: franz.gum@vero-sbrt.com.

Device

Device Recall MHITM2000/ VERO (TM)
  • Modelo / Serial
    Serial Numbers #s 201902 and 203901
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.
  • Descripción del producto
    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); 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