Events

Recall of McKesson Horizon Medical Imaging

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

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
    66301
  • Event Risk Class
    Class 2
  • Event Number
    Z-2318-2013
  • Event Initiated Date
    2013-09-04
  • Event Date Posted
    2013-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121962
  • 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
    Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
  • Action
    Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change.

Device

McKesson Horizon Medical Imaging
  • Model / Serial
    Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.
  • Product Description
    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.
  • Manufacturer
    Mckesson Information Solutions LLC

Manufacturer

Mckesson Information Solutions LLC
  • Manufacturer Address
    Mckesson Information Solutions LLC, 5995 Winward Plaza, Information Technology Business, Alpharetta GA 30005
  • Source
    USFDA