Retiro De Equipo (Recall) de Device Recall InGenuity CT 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
    61102
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1046-2012
  • Fecha de inicio del evento
    2011-12-08
  • Fecha de publicación del evento
    2012-02-16
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-03-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Design defect. philips learned of this device issue following their receipt of a customer complaint reporting that a 'gap' is created in the side covers when the gantry of the device is tilted to +30 degrees (forward tilt). a hazard to the operator/user presents itself if the operator puts his or her fingers or hand inside the gap and the gantry tilt is returned in position while the fingers or.
  • Acción
    The firm, Philips, sent an 'URGENT - Medical Device Correction Ingenuity CT***' letter dated December 08, 2011. The letter describes the affected product, the nature of the problem along witth the circumstances under which this problem can occur; the hazard involved and actions to be taken by the customer/user. The customers (operator/users) were instructed not to insert hands in the gap which will be located between the gantry and stationary support column located on either side of the CT System (illustrations are provided). The letter notifies the customers that a Philips representative will be visiting each customer site and installing a hardware upgrade through a Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at (1-800-722-9377, option 5; enter site 10 or follow prompts).

Device

  • Modelo / Serial
    The following Serial Numbers are subject to recall/software correction: 300003, 300004, 300005, and 300010.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: IN and OR; and countries of: Australia and Germany.
  • Descripción del producto
    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. || Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-a¿sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer

Manufacturer

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