Events

Recall of Device Recall Horizon Medical Imaging

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
    68431
  • Event Risk Class
    Class 2
  • Event Number
    Z-1728-2014
  • Event Initiated Date
    2014-05-29
  • Event Date Posted
    2014-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127692
  • 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
    Firm received a complaint that an unreported study performed that day could not be opened from the archive.
  • Action
    McKesson sent an Urgent Field Safety Notice dated May 20, 2014, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were informed that the potentially affected software versions will be corrected without removing the systems from their location. Customers were instructed to distribute the notice to all those within their organization who need to be aware and alert all those affilliated with their organization that are affected by this field safety notice. All customers receiving the Field Safety Notice should contact McKesson Support as soon as possible at 1-800-663-2533 to arrange installation of the software update. Customers with questions should contact the Customer Support Department and ask to speak to their Support Manager.

Device

Device Recall Horizon Medical Imaging
  • Model / Serial
    HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 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, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.
  • Product Description
    Horizon Medical Imaging || Horizon Medical Imaging 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