Z-1617-2014Class II

McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended...

Name: Z-1617-2014 McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended...
Creator: Mckesson Medical Immaging
Published: 2014-04-17
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2014-04-17 / Terminated / root cause: software

FDA source

Mckesson Medical Immaging began a recall of McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display... on 2014-04-17. FDA classified it as Class II and gives the reason as "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". 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-1617-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-17
Posted: 2014-05-13
Terminated: 2016-02-02
Recalling firm: Change Healthcare Canada Company
Product: 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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
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.
Quantity in commerce: 45
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 codes and lots: Model MR 12.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1617-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1617-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-13

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)