Z-3035-2011

Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon Medical Imaging is a...

Name: Z-3035-2011 Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon Medical Imaging is a...
Creator: Mckesson Information Solutions LLC
Published: 2011-02-02
License: https://open.fda.gov/license/

Mckesson Information Solutions, LLC / initiated 2011-02-02 / Terminated

FDA source

Mckesson Information Solutions LLC began a recall of Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon Medical Imaging is a medical image and information management application... on 2011-02-02. The reason FDA records is "Images for one patient may appear in the study of another patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3035-2011
Status: Terminated
Initiated: 2011-02-02
Posted: 2011-08-18
Terminated: 2012-10-04
Recalling firm: Mckesson Information Solutions, LLC
Product: Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. 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: Images for one patient may appear in the study of another patient.
FDA root cause: Other
Action: Mckesson Medical Imaging Group sent a URGENT FIELD SAFETY NOTICE letter dated June 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. On February 2, 2011, the McKesson Medical Imaging company initiated a process for applying an image display software update to the HMI systems at the hospital site that initiated the complaint. They were advised to contact McKesson Customer Support at 1-800-663-2533, to indicate whether they would like to receive the software update. They were advised to distribute the notification to all those within their organization who need to be aware and to alert other parties affiliated with their organization that are affected by this advisory notice.
Quantity in commerce: 438 devices
Distribution: Worldwide Distribution--USA (nationwide) Australia, Canada, Guam and the United Kingdom.
Product codes and lots: Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8

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)