FDA Device recall Z-2318-2013
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and inform…
- FDA Device
- Class II
- terminated
- Published 2013-10-09
On 2013-10-09 the FDA classified a Class II recall of McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and inform… by Mckesson Information Solutions, citing software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2318-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-04 |
| Published | 2013-10-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mckesson Information Solutions |
| Distribution | PR |
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.
Reason
Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Identifiers
| code_info | 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.…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. |
|---|
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-2318-2013%22
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