Events

Rappel de Device Recall IntelePACS

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 Intelerad Medical Systems.

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
    68719
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2267-2014
  • Date de mise en oeuvre de l'événement
    2014-07-03
  • Date de publication de l'événement
    2014-08-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128558
  • 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
    In specific situation a partially truncated file may be written to the intelepacs server. this partially truncated file still can be viewed by inteleviewer and inteleviewer will report to the user that the file in question is complete. this situation only occurs if a file is partially truncated.
  • Action
    Intelerad sent an Urgent Recall for Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a new software release will be installed on the system. Afterwards, an audit will be run on the the entire PACS to identify all image data that may have been truncated. Customers were requested to complete and return the attached Client Response Form.

Device

Device Recall IntelePACS
  • Modèle / numéro de série
    software versions 3-8-1 to 4-9-1
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
  • Description du dispositif
    IntelePACS software versions 3-8-1 to 4-9-1, || Product Usage: || IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
  • Manufacturer
    Intelerad Medical Systems

Manufacturer

Intelerad Medical Systems