Events

Recall of Device Recall Horizon Medical Imaging Systems

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
    55723
  • Event Risk Class
    Class 2
  • Event Number
    Z-1735-2010
  • Event Initiated Date
    2010-05-07
  • Event Date Posted
    2010-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91664
  • 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
    Voice clip issue: when the user is recording voice clips in horizon rad station, there is a potential for voice clips to be saved to the incorrect study of the same patient.
  • Action
    McKesson Medical Imaging Company issued an "Advisory Notice" dated May 7, 2010. Consignees were notified of the affected product and advised to contact McKesson Customer Support department to review their sites current configuration and install the appropriate product software update(s). For further information, contact McKesson Medical Imaging Customer Support at 1-800-663-2533. On June 19, 2010 the recall was amended to include the following actions to follow: Instead of highlighting the anchor study in the Patient Portfolio Sidebar before saving t he voice clip in the Patient Portfolio Sidebar, McKesson recommends that you save the voice clip to the desired study first, before browsing through other documents. A software update that prevents the problem from occurring is currently under development for all affected releases and will be available in approximately three months. Consignees will be notified when the software update is ready to be installed on their system.

Device

Device Recall Horizon Medical Imaging Systems
  • Model / Serial
    Horizon Medical Imaging (HMI) versions: 4.5, 4.6.1, 5.0 without PTF-RR310-601, 11.0.3, 11.0.4, 11.0.5, 11.0.6, 11.0.6 FR EXP2 without PTF-HMI11-649, 11.0.7, 11.0.8 without PTF-HMI11-615, 11.5 and 11.5.1 without PTF-HMI115-613. On June 29, 2010 the recall was amended to include: All installations of Horizon Medical imaging (HMI) 11.0.6, 11.0.8 and 11.5.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide (AK, AL, AR, AZ, CA, CO, FL, GA, IN, IA, IL, KY, LA, MA, MD, MI, NC, ND, NE, NM, NY, NV, OH, OR, PA, RI, SC, TN, TX, WY, VA and WV) and Canada
  • Product Description
    Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5. || 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