FDA Device recall Z-1182-2016
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1 by Mckesson Medical Immaging, citing mcKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1182-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-18 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mckesson Medical Immaging |
| Distribution | US |
Product
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
Reason
McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient.
Identifiers
| code_info | McKesson Radiology Versions- 12.1.1, 12.0; Horizon Medical Imaging Versions -11.9, 11.8, 11.7, 11.6, 11.5.2, 11.5.1,11.0.8, 5.0, 4.6.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1182-2016%22
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