Events

Retiro De Equipo (Recall) de AIRIS II, Altaire Magnetic Resonance Imaging Devices

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
    35100
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1104-06
  • Fecha de inicio del evento
    2006-04-28
  • Fecha de publicación del evento
    2006-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-11-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45322
  • 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
    Magnetic Resonance Imaging MRI - Product Code LNH
  • Causa
    Software anomaly-a software defect can cause the slice line indicator to become mis-positioned during multi-planar reconstructions (mpr) with the potential for patient mis-diagnosis.
  • Acción
    The firm''s Field Service personnel will apprise the customers of this situation during scheduled visits at each customer location. During this visit, the corrected software will be installed by the Hitachi Field Service Technician. The installation of the software upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of all units in their inventory as well as those units installed out-in-the-field will becompleted by 6/15/2006.

Device

AIRIS II, Altaire Magnetic Resonance Imaging Devices
  • Modelo / Serial
    Serial Numbers: Altaire - L217, L219, L221, L224 and L225; AIRIS II - C686-C688* [*The AIRIS units remained in Hitachi's inventory and were not distributed].
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas
  • Descripción del producto
    AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
  • 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