Events

Retiro De Equipo (Recall) de Device Recall BRILLIANCE VOLUME

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
    52214
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1582-2009
  • Fecha de inicio del evento
    2008-12-22
  • Fecha de publicación del evento
    2009-06-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82541
  • 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 anomaly. an artifact may appear in brain scans and brain perfusion studies, when using 80kv and a ua, ub, or uc filter with this ct scanning device.
  • Acción
    An "URGENT - Field Safety Notice" dated December 22, 2009 was issued via certified mail to affected customers. The letter described the affected product, problem, hazards involved, and actions for customers to take. Philips will provide customers with a software update for all affected systems within next 6 months. The firm also sent a second notification in the form of an "URGENT -Medical Device Correction" report dated January 29, 2009 which contained information noted in the "URGENT - Field Safety Notice". Direct questions to your local Philips representative or Philips Customer Care Center (1-800-722-9377), option 5: Other Imaging Systems, option 1: CT or to your local Philips Healthcare office.

Device

Device Recall BRILLIANCE VOLUME
  • Modelo / Serial
    Serial Numbers: 100001-100063, 100065-100073 and 100075-100076.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US including DC (states of CA, GA, IL, IN, KY, NY, MD, MN, OH, OR, and MD), Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Russia, South Korea, Switzerland, Taiwan, Canada, and Thailand.
  • Descripción del producto
    Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. || The 'Brilliance iCT' is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data taken at different Ganges 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