FDA Device recall Z-3004-2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation by Merge Healthcare, citing software issue may cause measurements to be displayed inaccurately.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3004-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-22 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Reason
Software issue may cause measurements to be displayed inaccurately.
Identifiers
| code_info | Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Merge Healthcare
- Merge PACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge OrthoPACS, medical imaging diagnostic workstation
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FDA Device · Class II · 2025-09-10 · Merge Healthcare - Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare - VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3004-2026%22
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