Events

Recall of Device Recall Horizon Medical Imaging (HMI)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mckesson Medical Immaging.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68799
  • Event Risk Class
    Class 2
  • Event Number
    Z-2121-2014
  • Event Initiated Date
    2014-05-05
  • Event Date Posted
    2014-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128763
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    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)
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Mckesson Medical Immaging, Suite 130-10711 Cambie Road, Richmond Canada British Columbia
  • Source
    USFDA