Class II — Merge Healthcare, Inc.
| Recalling firm | Merge Healthcare |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 298 sites potentially have the affected versions (290 of those in US) |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada, Belgium, Australia, Jordan, and the UK.. |
| Initiated | 2016-04-04 |
| Classified | 2017-03-29 |
| Terminated | 2020-04-10 |
| Recall number | Z-1697-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merge Healthcare, Inc. (Z-1697-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76851/
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