FDA Device recall Z-2238-2012
Horizon Medical Imaging system
- FDA Device
- Class II
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class II recall of Horizon Medical Imaging system by Mckesson Medical Imaging Group, citing there is a potential to save reports in RadReport with an Incorrect Final Status.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2238-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-29 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mckesson Medical Imaging Group |
| Distribution | US |
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).
Reason
There is a potential to save reports in RadReport with an Incorrect Final Status.
Identifiers
| code_info | Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2238-2012%22
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