Events

Recall of McKesson Radiology

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
    67014
  • Event Risk Class
    Class 2
  • Event Number
    Z-0556-2014
  • Event Initiated Date
    2013-10-15
  • Event Date Posted
    2013-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124515
  • 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
    Radiological Image Processing System - Product Code LLZ
  • Reason
    When merging two patient records into one patient record using mckesson radiology 12.0, the resulting patient record is missing the contrast allergy information for the second patient record.
  • Action
    Consignees were notified via letter (Field Safety Notice) on 10/15/2013.

Device

McKesson Radiology
  • Model / Serial
    MR 12.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MO, NY, TN, WV and France.
  • Product Description
    McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
  • 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