Events

Retiro De Equipo (Recall) de Device Recall CXR4CT (including Sceptre P3 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
    35086
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1079-06
  • 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=45240
  • 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, X-Ray, Tomography, Computed - Product Code JAK
  • Causa
    The device has a software anomaly which causes blank images to be created during multiplanar reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized.
  • Acción
    Hitachi Medical Systems America, Inc. was informed of a software-related problem with the 50mm scale displayed on filmed images. This problem was reported to the firm by their Japanese manufacturer. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. The firm issued a Device Correctioin Notice to their customers on 2/21/2006. The notice concerns the referenced software problem which results in the resizing of the images, as well as a second previously discovered problem which results in blank multi-planer reconstructions (MPR''s). According to the Device Correction Notice, a software upgrade has already been installed on all of the units in order to correct the MPRs problem [Ref: RES #35081, Correction Removal Report #1528028-01/31/06-003-C] In response to the resizing issue, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006, and this software upgrade 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 CXR4CT (including Sceptre P3 PET/CT)
  • Modelo / Serial
    CXR46201-46214 PC46002-46011
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The 16 devices were distributed to 11 states: Texas, Florida, Louisiana, Illinois, Connecticut, Ohio, Massachusetts, Wisconsin, Idaho, California, New Jersey
  • Descripción del producto
    Hitachi Emission Computed Tomography System || Hitachi CX-4 CT (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