Events

Recall of Device Recall McKesson Radiology 12.2 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 Imaging.

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
    76500
  • Event Risk Class
    Class 2
  • Event Number
    Z-1396-2017
  • Event Initiated Date
    2016-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153379
  • 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
    Issue for customers that use an emr login or legacy web url login or legacy web url login for mckesson radiology pacs that may result in missing images in a newly imported study, and/or study imports that remain in an "in-progress" status.
  • Action
    McKesson sent an Urgent Field Safety Notice on December 2, 2016 to customers with potentially affected software versions. The notice indicated that they were to contact McKesson to install a software update to correct the issue, and that they read and understood the Field Safety Notice.

Device

Device Recall McKesson Radiology 12.2 Picture Archive Communication System (PACS)
  • Model / Serial
    Model 12.2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AK, CA, FL, HI, KY, MD, MI, MS, NH, OH, PA, TN, TX, VT
  • Product Description
    McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
  • Manufacturer
    Mckesson Medical Imaging

Manufacturer

Mckesson Medical Imaging
  • Manufacturer Address
    Mckesson Medical Imaging, 10711 Cambie Rd Suite 130, Richmond Canada
  • Source
    USFDA