Z-2238-2012Class II

Horizon Medical Imaging system

Name: Z-2238-2012 Horizon Medical Imaging system
Creator: Mckesson Medical Imaging Group
Published: 2012-05-29
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2012-05-29 / Terminated / root cause: software

FDA source

Mckesson Medical Imaging Group began a recall of Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive... on 2012-05-29. FDA classified it as Class II and gives the reason as "There is a potential to save reports in RadReport with an Incorrect Final Status". 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-2238-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-08-22
Terminated: 2013-09-12
Recalling firm: Change Healthcare Canada Company
Product: Horizon Medical Imaging system. Product Usage: 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is a potential to save reports in RadReport with an Incorrect Final Status.
Root cause tag: software
FDA root cause: Software design
Action: McKesson sent an Urgent Field Safety Notice letter dated May 29, 2012 to all affected consignees. The letter identified the affected product, circumstances under which the issue occurs and immediate actions to be taken. Customers were advised to notify the Customer Support department that they have read and understood this Advisory Notice at 1-800-663-2533. For questions contact the Support Manager at the Customer Support department.
Quantity in commerce: 516 units
Distribution: Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.
Product codes and lots: Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2238-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2238-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-21

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)