FDA Device recall Z-2379-2016
Merge PACS software
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Merge PACS software by Merge Healthcare, citing the patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2379-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-30 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Reason
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Identifiers
| code_info | Versions: V6.0.2.0 MR2 and earlier |
|---|
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-2379-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.