Events

Retiro De Equipo (Recall) de Brilliance 64 and Ingenuity 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 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
    69045
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2664-2014
  • Fecha de inicio del evento
    2011-09-01
  • Fecha de publicación del evento
    2014-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129396
  • 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
    During a field test (a customer external evaluation period), the customer detected a problem in the cirs 4.0 beta 2 software. when using the cirs 4.0 beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. philips has disabled this feature at all sites evaluating 4.0 beta 2 software. philips will issue a software up.
  • Acción
    The firm, Philips, sent a Field Safety Notice (FSN 72800534) entitled "URGENT-Medical Device Correction" dated September 1, 2011 via mail on September 6, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to review the following information with all members of your staff who need to be aware of the contents of this communication and retain a copy with the equipment Instructions for Use. A Field Service Engineer will visit each site to install the corrected software. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).

Device

Brilliance 64 and Ingenuity CT
  • Modelo / Serial
    91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.
  • Descripción del producto
    The Brilliance 64 and Ingenuity CT 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.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA