Merge PACS versions 7 — Class II medical device recall Z-2062-2019
Terminated recall by Merge Healthcare, Inc., reported 2019-07-31, distributed nationwide. Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reve
| Recall number | Z-2062-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2019-07-11 |
| Classified | 2019-07-23 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2023-03-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA |
| Quantity | 179 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00842000100690, 00842000100737 |
Product
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Reason for recall
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2062-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.