Events

Rappel de IntelliSpace PACS

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Healthcare Informatics, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66560
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0269-2014
  • Date de mise en oeuvre de l'événement
    2013-10-14
  • Date de publication de l'événement
    2013-11-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122607
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, image processing, radiological - Product Code LLZ
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    All units of these IntelliSpace PACS.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and country: Canada.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA