FDA Device recall Z-1385-2017
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information managemen…
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information managemen… by Merge Healthcare, citing the software is not adding the correct tomo image.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1385-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-08 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Reason
The software is not adding the correct tomo image.
Identifiers
| code_info | Versions 11.0 and 11.0.1 |
|---|
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-1385-2017%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.