Events

Rappel de Device Recall Horizon Medical Imaging (HMI)

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 Immaging.

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
    68799
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2121-2014
  • Date de mise en oeuvre de l'événement
    2014-05-05
  • Date de publication de l'événement
    2014-07-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128763
  • 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 firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.
  • Action
    McKesson sent an Urgent Field Safety Notice dated May 5, 2014, to all affected customers informing them of the issue and advising them of the immediate actions to take to reduce the risk to the patient. These actions include - Users ensure that all expected images are display in the Image Viewer and PACS Administrators should engage McKesson Support for all issues with studies. McKesson is also providing a software solution to HMI systems that may be potentially affected by the problem to prevent future recurrence. Customers were instructed to contact McKesson Support as soon as possible at 1-800-663-2533 to acknowledge that they have read and understood the Field Safety Notice, and to arrange installation of the software update. Customers with questions were instructed to contact Customer Support and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556.

Device

Device Recall Horizon Medical Imaging (HMI)
  • Modèle / numéro de série
    HMI 4.5, HMI 4.6.1, HIM 5.0, HMI 5.0 Service Pack 6, HMI 5.0 Service Pack 7, HMI 5.0 Service Pack 8, HMI 11.0.6, HMI 11.0.6 FR EXP 2, HMI 11.0.7, HMI 11.0.8, HMI 11.5, HMI 11.5.1, HMI 11.5.2, HMI 11.6, HMI 11.7, HMI 11.8, HMI 11.9, MR 12.0
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NJ, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY,and France, Canada, Puerto Rico, Guam, Great Britain, Ireland, Australia.
  • Description du dispositif
    Horizon Medical Imaging || 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 Immaging

Manufacturer

Mckesson Medical Immaging
  • Adresse du fabricant
    Mckesson Medical Immaging, Suite 130-10711 Cambie Road, Richmond Canada British Columbia
  • Source
    USFDA