Events

Recall of 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 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
    68208
  • Event Risk Class
    Class 2
  • Event Number
    Z-1617-2014
  • Event Initiated Date
    2014-04-17
  • Event Date Posted
    2014-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127138
  • 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
    High priority alert icon was not displayed in the study list when there are no stat studies present. however, the high priority alert icon is visible when studies marked as stat priority exist in the study list.
  • Action
    On April 17, 2014, McKesson Medical Imaging Company initiated a process for applying a software solution to all McKesson Radiology customer systems that may be affected to prevent future occurrences of this issue. The systems with the potentially affected software versions will be corrected without removing the systems from their location.

Device

Picture Archive Communication System (PACS)
  • Model / Serial
    Model MR 12.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, CA, GA, ID, IL, IA, MD, MS, MO, NE, NV, NH, NY, NC, PA, TN, TX, VT, WA, WV, WY, and the countries of Canada and France.
  • Product Description
    McKesson Radiology-PACS. || McKesson Radiology is a medical image and information 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