Z-2318-2013Class II

McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6...

Name: Z-2318-2013 McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6...
Creator: Mckesson Information Solutions LLC
Published: 2013-09-04
License: https://open.fda.gov/license/

Mckesson Information Solutions, LLC / initiated 2013-09-04 / Terminated / root cause: software

FDA source

Mckesson Information Solutions LLC began a recall of McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management... on 2013-09-04. FDA classified it as Class II and gives the reason as "Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss". 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-2318-2013
Classification: Class II
Status: Terminated
Initiated: 2013-09-04
Posted: 2013-09-30
Terminated: 2017-02-06
Recalling firm: Mckesson Information Solutions, LLC
Product: McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Root cause tag: software
FDA root cause: Software change control
Action: Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change.
Quantity in commerce: 329 units
Distribution: Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.
Product codes and lots: Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2318-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2318-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30

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)