FDA Device recall Z-1426-2017
DR Systems Unity PACS software, now known as Merge Unity PACS
- FDA Device
- Class II
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class II recall of DR Systems Unity PACS software, now known as Merge Unity PACS by Merge Healthcare, citing reports were missing demographic header information when they were faxed to referring physicians.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1426-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-08 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | CA, MT, PA, TX |
Product
DR Systems Unity PACS software, now known as Merge Unity PACS
Reason
Reports were missing demographic header information when they were faxed to referring physicians.
Identifiers
| code_info | Version 11.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Merge Healthcare
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-09-02 · Merge Healthcare - Merge PACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCS…
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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1426-2017%22
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