Events

Rappel de Device Recall Horizon Medical Imaging

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
    73452
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1182-2016
  • Date de mise en oeuvre de l'événement
    2016-02-18
  • Statut de l'événement
    Completed
  • 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=144219
  • 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
    Mckesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. this issue may cause incorrect images to be displayed for a patient.
  • Action
    McKesson sent an Urgent Field Safety Notice dated February 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate actions to take to reduce the risk to patient All customers receiving this safety notice must contact McKesson Support as soon as possible at 1-800-663-2533 US/Canada and International Toll Free Radiology - 00 800 626 20009: 1) To acknowledge that they have read and understood this Field Safety Notice And 2) Arrange installation of software update/upgrade. This notice should be distributed to all personnel within your organization who need to be aware of this issue and the required actions, and alert other affiliated parties that are affected by this Field Safety Notice. For further questions, please call (404) 338-3556

Device

Device Recall Horizon Medical Imaging
  • Modèle / numéro de série
    McKesson Radiology Versions- 12.1.1, 12.0; Horizon Medical Imaging Versions -11.9, 11.8, 11.7, 11.6, 11.5.2, 11.5.1,11.0.8, 5.0, 4.6.1
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the states of : AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY., and the countries of : Guam, Great Britain, France, Canada, Ireland and Australia
  • Description du dispositif
    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
  • 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