Events

Retiro De Equipo (Recall) de Device Recall The Brilliance iCT and iCT SP

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
    61866
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1791-2012
  • Fecha de inicio del evento
    2012-05-07
  • Fecha de publicación del evento
    2012-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109268
  • 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
    Philips is issuing a software update (version 3.2.4) to the brilliance ict and ict sp systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. a review was conducted of all nonconformances that are fixed by the software upgrade. none of these nonconformances result in unacceptable hazards. the nonconformance documented below had the highest sc.
  • Acción
    Philips sent an Urgent - Medical Device Correction letter dated May 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. Customers were instructed to review the Release Document provided them with information about the software update, new feature and enhancements. For North America and Canada customers should contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Side ID or follow the prompts. For questions regarding this recall call 440-483-4918.

Device

Device Recall The Brilliance iCT and iCT SP
  • Modelo / Serial
    Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, CA, DC, DE, FL, GA, IA, IN, MA, MD, MN, MS, NC, NY, OH, OR, PA, TN, TX, VT, WA & WV and the countries of Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, EGYPT, France, Germany, Greece, Hungary, ICELAND, India, Indonesia, Israel, ISRAEL, Italy, Japan, Jordan, Lebanon, Netherlands, New Zealand, PHILIPPINES, POLAND, Portugal, Qatar, Russia, SINGAPORE, South Korea, SPAIN, SWEDEN, Switzerland, Taiwan, THAILAND, Turkey, UNITED KINGDOM & Uzbekistan.
  • Descripción del producto
    The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. || The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • 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