Merge PACS software — Class II medical device recall Z-0599-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-11-23, distributed nationwide. The software did not show unviewed images when the last view was skipped. The physician may potentially misdia
| Recall number | Z-0599-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-03-28 |
| Classified | 2016-11-16 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2021-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 534 sites |
| Reason classes | software |
Product
Merge PACS software. Product Usage: 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
The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.
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-0599-2017. 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.