Events

Rappel de Device Recall McKesson Radiology (MR) Picture Archive Communication System (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 Mckesson Medical Imaging Group.

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
    75194
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2872-2016
  • Date de mise en oeuvre de l'événement
    2016-07-12
  • Date de publication de l'événement
    2016-09-22
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149631
  • 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
    The stat priority icon was not displayed in the study list when the study was opened.
  • Action
    McKesson sent an Urgent Field Safety Notice on July 12, 2016 to customers with potentially affected software versions. The letter requested that they contact McKesson to acknowledge that they read and understood the Field Safety Notice and to arrange installation of software update/upgrade. Customers with questions were instructed call the McKesson Support department and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556.

Device

Device Recall McKesson Radiology (MR) Picture Archive Communication System (PACS)
  • Modèle / numéro de série
    McKesson Radiology versions 12.1.1 and 12.2
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA WV, WI, WY, and Internationally to Canada, France, Great Britain and Ireland
  • Description du dispositif
    McKesson Radiology, versions 12.1.1 and 12.2 || McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
  • Manufacturer
    Mckesson Medical Imaging Group

Manufacturer

Mckesson Medical Imaging Group
  • Adresse du fabricant
    Mckesson Medical Imaging Group, 10711 Cambie Rdsuite 130, Richmond Canada British Columbia
  • Source
    USFDA