Events

Retiro De Equipo (Recall) de Device Recall Echelon, Echelon Oval and Oasis MR imaging device systems

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
    65438
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1559-2013
  • Fecha de inicio del evento
    2013-01-31
  • Fecha de publicación del evento
    2013-06-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118892
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. the software error can occur randomly. the error causes an image in the processed dataset to have the same unique identifier (uid) as in the scanning dataset. the processed image is stored in the place of the original image, which is lost.
  • Acción
    Hitachi sent a Device Correction Notice beginning on January 31,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is targeted to start by March 1, 2013. All sites will be visited by Hitachi Service to perform corrections. All letters are recorded by tracking number and date received by the customers. For further questions please call 800-800-3106 x 3720.

Device

Device Recall Echelon, Echelon Oval and Oasis MR imaging device systems
  • Modelo / Serial
    The following serial numbers are associated with this recall: Echelon - V061, V062, and V065 Oasis - M009, M017, M067, M071, M084, M106-M108, M110-M141 inclusive, and M952 Echelon Oval - Y001-Y005 inclusive
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, IL, IN, KS, KY, MD, NC, ND, NY, OH, OR, PA, TX, VA, WA, and WI. One (1) system unit was also distributed to Mexico.
  • Descripción del producto
    Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. || The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities.
  • 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