Events

Retiro De Equipo (Recall) de Device Recall IntelePACS

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 Intelerad Medical Systems.

¿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
    68719
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2267-2014
  • Fecha de inicio del evento
    2014-07-03
  • Fecha de publicación del evento
    2014-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128558
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    In specific situation a partially truncated file may be written to the intelepacs server. this partially truncated file still can be viewed by inteleviewer and inteleviewer will report to the user that the file in question is complete. this situation only occurs if a file is partially truncated.
  • Acción
    Intelerad sent an Urgent Recall for Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a new software release will be installed on the system. Afterwards, an audit will be run on the the entire PACS to identify all image data that may have been truncated. Customers were requested to complete and return the attached Client Response Form.

Device

Device Recall IntelePACS
  • Modelo / Serial
    software versions 3-8-1 to 4-9-1
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
  • Descripción del producto
    IntelePACS software versions 3-8-1 to 4-9-1, || Product Usage: || IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
  • Manufacturer
    Intelerad Medical Systems

Manufacturer

Intelerad Medical Systems