Events

Retiro De Equipo (Recall) de Device Recall MHITM2000/ 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 Hitachi Ltd., Medical System Operations Group.

¿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
    79439
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1585-2018
  • Fecha de inicio del evento
    2017-12-08
  • 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=162328
  • 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
    Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
  • Acción
    Hitachi sent a Field Safety Notice letter dated November 28, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter includes instructions for the user on how to verify patient position even with the software issue. The letter also explains that correction software is being developed with a tentative release date of, "End of January, 2018.". A customer service representative will contact affected customers about installing the software. For questions contact your our Customer Service Representative.

Device

Device Recall MHITM2000/ VERO"
  • Modelo / Serial
    Serial Number: 203919
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution in the state of NY.
  • Descripción del producto
    MHI-TM2000 Linear Accelerator System || Product Usage: || 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
    Hitachi Ltd., Medical System Operations Group

Manufacturer

Hitachi Ltd., Medical System Operations Group
  • Dirección del fabricante
    Hitachi Ltd., Medical System Operations Group, 2-1, Shintoyofuta, Kashiwa Japan
  • Empresa matriz del fabricante (2017)
    Hitachi Ltd
  • Source
    USFDA