iConnect Access software — Class II medical device recall Z-0611-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-11-23, distributed nationwide. Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or mor
| Recall number | Z-0611-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-05-25 |
| Classified | 2016-11-17 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2019-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 60 sites |
| Reason classes | software |
Product
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
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-0611-2017. 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.