Events

Retiro De Equipo (Recall) de Ingenuity CT XRay 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 Philips Medical Systems (Cleveland) 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
    59886
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0361-2012
  • Fecha de inicio del evento
    2011-09-06
  • Fecha de publicación del evento
    2011-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103934
  • 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
    Software errors. a number of non-conformances were logged during in-house testing and external validation testing of brilliance 64 and ingenuity ct software version 4.0 beta 2. the non-conformances are due to software errors identified in these device systems.
  • Acción
    Philips Healthcare released a 'Field Change Order' (FCO #72800542) on September 15, 2011. Philips sent an URGENT - Medical Device Correction letter dated October 10, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to the situation. The letter was mailed by Philips to their customers on October 27, 2011. The letter provided information telling the customer how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Release Notes which were provided to each customer location once the software update was installed. The letter notified the customer that a Philips representative would be installing a software upgrade in order to address the referenced software issues free-of-charge, through a Field Change Order. The letter closes by providing information which all customers in Canada and North America can use to contact the firm through a toll-free telephone number 1-800-722-9377, option 5; enter side ID or follow the prompts. For questions regarding this recall call 440-483-4918.

Device

Ingenuity CT XRay System
  • Modelo / Serial
    Model #728326, 510(k) #KK033326, Serial Numbers: 300010 and 300018.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Ohio and the countries of Australia, China, Belgium, Israel, and Sweden
  • Descripción del producto
    Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. || The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA