Merge PACS software — Class II medical device recall Z-2591-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-06-21, distributed nationwide. When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causin
| Recall number | Z-2591-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2017-05-08 |
| Classified | 2017-06-15 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2019-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 47 sites |
Product
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Reason for recall
When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
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-2591-2017. 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.