Events

Retiro De Equipo (Recall) de Device Recall iSite PACS with iSite ViewForum Applications

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.

¿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
    58044
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1882-2011
  • Fecha de inicio del evento
    2011-02-23
  • Fecha de publicación del evento
    2011-04-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98096
  • 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, image processing, radiological - Product Code LLC
  • Causa
    A software anomaly that occurs when clinicians use volume vision to view images in 3d and uses the measurement tool to measure regions of interest. this could lead to an incorrect interpretation of the measurements which could cause an incorrect diagnosis and incorrect treatment plan.
  • Acción
    Philips sent an Urgent Field Safety Notice letter dated February 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to assure that all colleagues were aware of the problem. When using the Volume Vision software, check the correctness of measurements (graphics and numerical values) prior to saving a captured image containing measurements. Save captured images containing measurements immediately after creating them and before altering the measurements in the original image view. For any subsequent measurements, create a new capture and save it immediately. For further information or support concerning this issues, customers should contact their local Philips representative at +1-877-328-2808.

Device

Device Recall iSite PACS with iSite ViewForum Applications
  • Modelo / Serial
    All units of these iSite PACS.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, || Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101, and 4.1.110 || ; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA || ViewForum Applications: iSite ViewForum Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. iSite ViewForum Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. iSite ViewForum Applications performs viewing, image manipulation, communication, printing, and quantification of images.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Dirección del fabricante
    Philips Medical Systems, 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA