FDA Device recall Z-2121-2014
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve…
- FDA Device
- Class II
- terminated
- Published 2014-08-06
On 2014-08-06 the FDA classified a Class II recall of Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve… by Mckesson Medical Immaging, citing the firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the im….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2121-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-05 |
| Published | 2014-08-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mckesson Medical Immaging |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY |
Product
Horizon Medical Imaging It 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.
Reason
The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.
Identifiers
| code_info | HMI 4.5, HMI 4.6.1, HIM 5.0, HMI 5.0 Service Pack 6, HMI 5.0 Service Pack 7, HMI 5.0 Service Pack 8, HMI 11.0.6, HMI 11…HMI 4.5, HMI 4.6.1, HIM 5.0, HMI 5.0 Service Pack 6, HMI 5.0 Service Pack 7, HMI 5.0 Service Pack 8, HMI 11.0.6, HMI 11.0.6 FR EXP 2, HMI 11.0.7, HMI 11.0.8, HMI 11.5, HMI 11.5.1, HMI 11.5.2, HMI 11.6, HMI 11.7, HMI 11.8, HMI 11.9, MR 12.0 |
|---|
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-2121-2014%22
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