Events

Retiro De Equipo (Recall) de IntelliSpace PACS

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 Healthcare Informatics, 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
    66560
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0269-2014
  • Fecha de inicio del evento
    2013-10-14
  • Fecha de publicación del evento
    2013-11-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122607
  • 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 LLZ
  • Causa
    Philips healthcare became aware of a software problem with the intellispace pacs system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. the missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.
  • Acción
    Philips sent an Urgent Field Safety Notice dated October 14, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please review the following with all radiology technicians who use lntelliSpace BY CUSTOMER/USER PACS: " Assure you and your colleagues are aware of the problem. " Verify that all images sent for each study are present on the iVault before the images are purged from the modality. o Use the image count from the lower right corner of the thumbnails as seen in Enterprise only. Single images (such as CR, DX and MG) show no image count, so the user should count those thumbnails without image counts as one. Add all the numbers up to come up with the total number of viewable images, stored to lntelliSpace. " Compare number of images sent from the modality and those sent from other 3rd party source to image count in IntelliSpace PACS. " If the image count on the modality or 3 party source indicates there are more images to the study than are present on the iVault, the study should be resent from the modality and/or 3 party source. " Resending the studies will typically correct the problem but the technician should again verify the image count is correct. If you need any further information or support concerning this issue, please INFORMATION AND contact your Philips representative or contact Care at isitecare@philips.com. Please call (650) 293-2300 for further questions.

Device

IntelliSpace PACS
  • Modelo / Serial
    All units of these IntelliSpace PACS.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and country: Canada.
  • Descripción del producto
    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA || IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
  • Manufacturer
    Philips Healthcare Informatics, Inc.

Manufacturer

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