iConnect Enterprise Archive — Class II medical device recall Z-1697-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-04-05, distributed nationwide. The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison
| Recall number | Z-1697-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-04-04 |
| Classified | 2017-03-29 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2020-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, GB, JO |
| Quantity | 298 sites |
Product
iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data
Reason for recall
The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.
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-1697-2017. 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.