Merge PACS software — Class II medical device recall Z-2363-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-08-17. When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image m
| Recall number | Z-2363-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-02-05 |
| Classified | 2016-08-08 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2016-10-25 |
| Countries outside the US | AU |
| Quantity | 49 sites |
Product
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Reason for recall
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
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-2363-2016. 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.