Z-2121-2014Class II

Horizon Medical Imaging It is a medical image and information management application that is intended to...

Name: Z-2121-2014 Horizon Medical Imaging It is a medical image and information management application that is intended to...
Creator: Mckesson Medical Immaging
Published: 2014-05-05
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2014-05-05 / Terminated / root cause: software

FDA source

Mckesson Medical Immaging began a recall of Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and... on 2014-05-05. FDA classified it as Class II and gives the reason as "The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images". 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-2121-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-05
Posted: 2014-07-28
Terminated: 2017-04-13
Recalling firm: Change Healthcare Canada Company
Product: Horizon Medical Imaging 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 firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.
Root cause tag: software
FDA root cause: Software design
Action: McKesson sent an Urgent Field Safety Notice dated May 5, 2014, to all affected customers informing them of the issue and advising them of the immediate actions to take to reduce the risk to the patient. These actions include - Users ensure that all expected images are display in the Image Viewer and PACS Administrators should engage McKesson Support for all issues with studies. McKesson is also providing a software solution to HMI systems that may be potentially affected by the problem to prevent future recurrence. Customers were instructed to contact McKesson Support as soon as possible at 1-800-663-2533 to acknowledge that they have read and understood the Field Safety Notice, and to arrange installation of the software update. Customers with questions were instructed to contact Customer Support and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556.
Quantity in commerce: 659 units
Distribution: Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NJ, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY,and France, Canada, Puerto Rico, Guam, Great Britain, Ireland, Australia.
Product codes and lots: HMI 4.5, HMI 4.6.1, HIM 5.0, HMI 5.0 Service Pack 6, HMI 5.0 Service Pack 7, HMI 5.0 Service Pack 8, HMI 11.0.6, HMI 11.0.6 FR EXP 2, HMI 11.0.7, HMI 11.0.8, HMI 11.5, HMI 11.5.1, HMI 11.5.2, HMI 11.6, HMI 11.7, HMI 11.8, HMI 11.9, MR 12.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2121-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2121-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-28

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)