Events

Retiro De Equipo (Recall) de Device Recall Brilliance 16 Computed Tomography XRay Scanning 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
    61762
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1690-2012
  • Fecha de inicio del evento
    2012-03-26
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108942
  • 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
    Component defect. following their receipt of a customer complaint, philips medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's ct scanning systems were not manufactured to specification and may crack.
  • Acción
    Philips issued an 'URGENT Medical Device Correction' letter dated March 27, 2012 to all affected customers. The letter identified the affected products, problem, hazard involved, how to identify affected products, and actions to be taken by customer/user. The letter informed customers that Philips intends to dispatching service personnel to each customer site in order to correct this issue. In the meantime, the letter recommend customer to contact their Philips representative if they hear unusual noises when moving the couch vertically, or if there is unintended vertical motion of the couch. For questions 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

Device Recall Brilliance 16 Computed Tomography XRay Scanning System
  • Modelo / Serial
    Serial Numbers: 6205, 6220, 6129, 6180, 6132, 6158, 6154, 6229, 6321, 6152
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - U.S. (Nationwide) including the states of: CA, FL,, HI, IA, IN, KY, LA, MA,, MI, MO, MS. NM, NV, OH, PA, PA, SC, TN, TX, WA, and Puerto Rico
  • Descripción del producto
    Brilliance 16 - Model #728246, CT Scanning System is subject to recall/correction || Product Usage: || The Brilliance 6, 16, 40 64, Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are 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 Road, Cleveland OH 44143-2131
  • Source
    USFDA