Events

Recall of Device Recall Horizon Medical Imaging, Picture Archive Communication System (PACS).

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
    67374
  • Event Risk Class
    Class 2
  • Event Number
    Z-0976-2014
  • Event Initiated Date
    2013-12-23
  • Event Date Posted
    2014-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125360
  • 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
    Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.
  • Action
    McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.

Device

Device Recall Horizon Medical Imaging, Picture Archive Communication System (PACS).
  • Model / Serial
    HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; 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 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
  • Product Description
    Horizon Medical Imaging, Picture Archive Communication System (PACS).
  • 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