Events

Retiro De Equipo (Recall) de Device Recall Computed Tomography XRay System MX 8000 IDT 16

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
    56508
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0133-2011
  • Fecha de inicio del evento
    2010-07-27
  • Fecha de publicación del evento
    2010-10-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94177
  • 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 healthcare has decided to recall the computed tomography x-ray system mx 8000 idt due to the fact that the software upgrade for the mx 8000 idt 16 v4.2.1 may not provide the optional collimation of 4x4.5 (18mm). if the customer does not verify the increment and thickness coincide with the newly selected collimation suggested by the conversion report, there is potential for a 6mm gap to ap.
  • Acción
    Philips Medical Systems (Cleveland), Inc. sent an URGENT - Field Safety Notice dated July 29, 2010 and August 23, 2010 to all customers. The notices identified the product, the problem, and the steps to be taken. Customers were instructed to locate and correct the error. Field Service Engineers were to visit each site to update the software For further information customers were to contact their local Philips Customer Care Center at 1-800-722-9377

Device

Device Recall Computed Tomography XRay System MX 8000 IDT 16
  • Modelo / Serial
    Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was sold in the following states: CA, DE, IN,OR, MA, NV, TN. Product was also sold in Canada and Australia
  • Descripción del producto
    Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056. || 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