Z-2872-2016Class II

McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication...

Name: Z-2872-2016 McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication...
Creator: Mckesson Medical Imaging Group
Published: 2016-07-12
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2016-07-12 / Terminated / root cause: software

FDA source

Mckesson Medical Imaging Group began a recall of McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information... on 2016-07-12. FDA classified it as Class II and gives the reason as "The STAT priority icon was not displayed in the Study List when the study was opened". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2872-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-12
Posted: 2016-09-22
Terminated: 2019-11-20
Recalling firm: Change Healthcare Canada Company
Product: McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It 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 imaging systems.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The STAT priority icon was not displayed in the Study List when the study was opened.
Root cause tag: software
FDA root cause: Software design
Action: McKesson sent an Urgent Field Safety Notice on July 12, 2016 to customers with potentially affected software versions. The letter requested that they contact McKesson to acknowledge that they read and understood the Field Safety Notice and to arrange installation of software update/upgrade. Customers with questions were instructed call the McKesson Support department and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556.
Quantity in commerce: 164 devices
Distribution: Worldwide Distribution - US including AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA WV, WI, WY, and Internationally to Canada, France, Great Britain and Ireland
Product codes and lots: McKesson Radiology versions 12.1.1 and 12.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2872-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2872-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-22

Product code LLZ

K043146Class IIHorizon Medical ImagingMckesson Medical Imaging Company / cleared 2005-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)