Z-0976-2014Class II

Horizon Medical Imaging, Picture Archive Communication System (PACS)

Name: Z-0976-2014 Horizon Medical Imaging, Picture Archive Communication System (PACS)
Creator: Mckesson Information Solutions LLC
Published: 2013-12-23
License: https://open.fda.gov/license/

Mckesson Information Solutions, LLC / initiated 2013-12-23 / Terminated / root cause: software

FDA source

Mckesson Information Solutions LLC began a recall of Horizon Medical Imaging, Picture Archive Communication System (PACS) on 2013-12-23. FDA classified it as Class II and gives the reason as "Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from 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-0976-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-23
Posted: 2014-02-12
Terminated: 2017-04-25
Recalling firm: Mckesson Information Solutions, LLC
Product: Horizon Medical Imaging, Picture Archive Communication System (PACS).
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.
Root cause tag: software
FDA root cause: Software design
Action: McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.
Quantity in commerce: 618 units
Distribution: U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
Product codes and lots: HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; 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 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0976-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0976-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-12

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)