Events

Retiro De Equipo (Recall) de Device Recall Philips Healthcare Ingenuity Core

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
    74820
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2657-2016
  • Fecha de inicio del evento
    2016-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148524
  • 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
    After upgrading to 3.6.7 software version via fco72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the ct images. this issue can occur on gated ct helical reconstruction that is not planned at iso-center (0,0). if the region of interest is not visualized in the images, a ct rescan may be performed.
  • Acción
    Customers were sent a letter dated July 28, 2016 informing them of the problem, under what circumstances it can occur and the actions that the customer can take to minimize the effect of the problem. The letter also includes the actions planned by Philips to correct the problem. Philips plans on releasing a field change order (FCO) to correct the affected systems. If you need any 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 (1 -800-722-9377).

Device

Device Recall Philips Healthcare Ingenuity Core
  • Modelo / Serial
    728321 -- Ingenuity Core  310004 310005 310012 310016 310020 310021 310027 310028 310033 310034 310041 310044 310045 310057 310061 310065 310072 310074 310076 310077 310078 310094 310099 310100 310103 310105 310117 310120 310122 310135
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
  • Descripción del producto
    Ingenuity Core, Model number 728321 || Product Usage: || 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.
  • 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