Z-1396-2017Class II

McKesson Radiology 12.2 - Picture Archive Communication System (PACS)

Name: Z-1396-2017 McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
Creator: Mckesson Medical Imaging
Published: 2016-12-02
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2016-12-02 / Terminated / root cause: software

FDA source

Mckesson Medical Imaging began a recall of McKesson Radiology 12.2 - Picture Archive Communication System (PACS) on 2016-12-02. FDA classified it as Class II and gives the reason as "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...". 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-1396-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Posted: 2017-03-02
Terminated: 2017-11-24
Recalling firm: Change Healthcare Canada Company
Product: McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 17
Distribution: AK, CA, FL, HI, KY, MD, MI, MS, NH, OH, PA, TN, TX, VT
Product codes and lots: Model 12.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1396-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1396-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-03-02

Product code LLZ

K140909Class IIMckesson RadiologyMckesson Medical Imaging Company / cleared 2014-07-02

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)