Z-1728-2014Class II

Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application...

Name: Z-1728-2014 Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application...
Creator: Mckesson Medical Immaging
Published: 2014-05-29
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2014-05-29 / Terminated / root cause: software

FDA source

Mckesson Medical Immaging began a recall of Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store... on 2014-05-29. FDA classified it as Class II and gives the reason as "Firm received a complaint that an unreported study performed that day could not be opened from the archive". 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-1728-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Posted: 2014-06-06
Terminated: 2017-03-31
Recalling firm: Change Healthcare Canada Company
Product: Horizon Medical Imaging Horizon Medical Imaging 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: Firm received a complaint that an unreported study performed that day could not be opened from the archive.
Root cause tag: software
FDA root cause: Software design
Action: McKesson sent an Urgent Field Safety Notice dated May 20, 2014, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were informed that the potentially affected software versions will be corrected without removing the systems from their location. Customers were instructed to distribute the notice to all those within their organization who need to be aware and alert all those affilliated with their organization that are affected by this field safety notice. All customers receiving the Field Safety Notice should contact McKesson Support as soon as possible at 1-800-663-2533 to arrange installation of the software update. Customers with questions should contact the Customer Support Department and ask to speak to their Support Manager.
Quantity in commerce: 659
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, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.
Product codes and lots: HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1728-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1728-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-06

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)