Events

Retiro De Equipo (Recall) de Device Recall Hitachi CXR4 CT (including SceptreP3 PET/CT)

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
    35081
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1078-06
  • Fecha de inicio del evento
    2006-02-21
  • Fecha de publicación del evento
    2006-06-03
  • 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=45234
  • 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
    Tomography X-ray System - Product Code JAK
  • Causa
    The device has a software anomaly which affects the system's ability to create multiplanar reconstructions (mpr). some images from the resulting series do not display correctly, or display at all, when mpr was run on them.
  • Acción
    Hitachi Medical Systems America, Inc. became aware of an intermittent problem in the Multi-planar Reconstruction process when covering long ranges that could result in blank frames in the displayed reconstructions. HMSA also discovered a second software-related problem with the 50mm scale displayed on filmed images. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. Software corrections have already been installed on all units in order to correct the first of these problems (MPRs). According to the firm''s Device Notification Letter issued on 2/21/2006, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006 and this correction will be performed by HMSA''s service personnel during each customer''s next scheduled PM. The Device Notification Letter also instructs the customers to call their Field Service Representatives or the HMSA Applications Helpline if they have any questions about the notice, or if any additional problems are encountered.

Device

Device Recall Hitachi CXR4 CT (including SceptreP3 PET/CT)
  • Modelo / Serial
    Serial Number: CXR46201-46213 PC 46002-36011
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The recalled MRI systems were distributed throughout the continental United States.
  • Descripción del producto
    Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
  • 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