Events

Retiro De Equipo (Recall) de Device Recall Hitachi Altaire Magnetic Resonance Imaging Device

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 Medical Systems America Inc.

¿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
    34856
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1103-06
  • Fecha de inicio del evento
    2006-01-27
  • Fecha de publicación del evento
    2006-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-11-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44831
  • 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
    MRI Magnetic Resonance Imaging - Product Code LNH
  • Causa
    Circuit failure-there is the potential risk of the phase loss detector safety device (phsen pcb) malfunctioning in the event of a power loss. the circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost.
  • Acción
    The recalling firm sent a Device Correction Letter dated 1/27/06 to all of their customers. The letter informs the customers of the problem in the (PHSEN PCB) and notifies the customers that an HMSA Field Service Technician will be performing a PCB modification to the unit, on-site, during their next scheduled preventative maintenance visit. Should the customer wish to have the modification performed prior to the representative''s scheduled visit, the letter says that they can telephone their local Field Service Rep. and make arrangements to have the modification performed at their convenience.

Device

Device Recall Hitachi Altaire Magnetic Resonance Imaging Device
  • Modelo / Serial
    L001 thru L223.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide-The device was distributed to consignees located throughout the United States.
  • Descripción del producto
    Hitachi Altaire Magnetic Resonance Imaging System
  • Manufacturer
    Hitachi Medical Systems America Inc

Manufacturer

Hitachi Medical Systems America Inc
  • Dirección del fabricante
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • Empresa matriz del fabricante (2017)
    Hitachi Ltd
  • Source
    USFDA