Events

Recall of Device Recall Horizon Medical Imaging system.

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

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
    62567
  • Event Risk Class
    Class 2
  • Event Number
    Z-2238-2012
  • Event Initiated Date
    2012-05-29
  • Event Date Posted
    2012-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111058
  • 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
    There is a potential to save reports in radreport with an incorrect final status.
  • Action
    McKesson sent an Urgent Field Safety Notice letter dated May 29, 2012 to all affected consignees. The letter identified the affected product, circumstances under which the issue occurs and immediate actions to be taken. Customers were advised to notify the Customer Support department that they have read and understood this Advisory Notice at 1-800-663-2533. For questions contact the Support Manager at the Customer Support department.

Device

Device Recall Horizon Medical Imaging system.
  • Model / Serial
    Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.
  • Product Description
    Horizon Medical Imaging system. || Product Usage: || 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
  • Manufacturer
    Mckesson Medical Imaging Group

Manufacturer

Mckesson Medical Imaging Group
  • Manufacturer Address
    Mckesson Medical Imaging Group, 10711 Cambie Rdsuite 130, Richmond Canada British Columbia
  • Source
    USFDA