Events

Rappel de Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup

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 Carestream Health 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
    66306
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0213-2014
  • Date de mise en oeuvre de l'événement
    2013-09-16
  • 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
    2015-12-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121975
  • 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
    Carestream health, inc. has issued a recall when using the carestream client workstation where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application due to a software problem.
  • Action
    Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time. For questions regarding this recall call 1-800-328-2910.

Device

Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup
  • Modèle / numéro de série
    Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1308519
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.
  • Description du dispositif
    Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup || The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
  • Manufacturer
    Carestream Health Inc.

Manufacturer

Carestream Health Inc.
  • Adresse du fabricant
    Carestream Health Inc., 150 Verona St, Rochester NY 14608-1733
  • Société-mère du fabricant (2017)
    ONEX Corp
  • Source
    USFDA