Merge PACS software — Class II medical device recall Z-2303-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-08-10, distributed nationwide. A migrated study that has annotations will display the annotations, but when a prior study is loaded that shou
| Recall number | Z-2303-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-01-30 |
| Classified | 2016-07-29 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2021-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, GB, JO, NZ |
| Quantity | 208 sites |
Product
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Reason for recall
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
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-2303-2016. 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.