Events

Retiro De Equipo (Recall) de Device Recall Altair, Airis Elite, AIRIS II MRI System

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
    35087
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0910-06
  • Fecha de inicio del evento
    2006-02-21
  • Fecha de publicación del evento
    2006-05-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45241
  • 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 - Product Code LNH
  • Causa
    The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
  • Acción
    The recalling firm plans to notify their customers of this recall/soft ware correction during a scheduled visit to be conducted at each customer site by a Hitachi Field Service Technician. During the visit, the necessary corrective software will be installed. The visits/corrections began on: 2/21/06.

Device

Device Recall Altair, Airis Elite, AIRIS II MRI System
  • Modelo / Serial
    L001-L225 - Altaire  C001-C693* - AIRIS II C701-C790 - AIRIS II Upgrades  H001-H091 - AIRIS Elite  H701-H748* - AIRIS Elite Upgrades   *The firm informed CIN-DO in their status reports for May, 2006 and again in August, 2007, that duplication was found in the number of system units originally reported to CIN-DO in early 2006. Ten (10) of the AIRIS II System units had been previously upgraded to AIRIS Elite units [System Unit Numbers: C012, C014, C032, C063, C111, C138, C263, C347, and C495] and are these numbers are reflected in the total # of AIRIS Elite System Unit Numbers listed above*  **By the same token, *eight (8) AIRIS Elite Upgrades [System ID Numbers: H735, H736, H740, H743, H745, H746, H747 & H748] were reportedly installed well after the corrective action was underway (7/28/06 to 11/24/2006) and were not-subject to corrective action. As a result, the total # of affected system units/customers has been revised to reflect the number reported by the firm [1129] beginning with their May, 2006 status report and continuing through to their final communication to CIN-DO dated 8/21/2007. - clp
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Magnetic Resonance Imaging Device
  • 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