iConnect Enterprise Archive software — Class II medical device recall Z-1700-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-04-05, distributed nationwide. The versions allow images to be stored without pixel data, resulting in the system not being able to present a
| Recall number | Z-1700-2017 |
|---|---|
| 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 | 2020-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 371 sites |
Product
iConnect Enterprise Archive software.
Reason for recall
The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining 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-1700-2017. 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.