FDA Device recall Z-1697-2017
iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and co…
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and co… by Merge Healthcare, citing 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 pro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1697-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-04 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | Versions 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.2, 8.40.2.1, 8.40.2.2, 8.70, 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, 9.…Versions 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.2, 8.40.2.1, 8.40.2.2, 8.70, 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.2.0, 9.3.0, 9.3.1, 9.4, 9.4.1, 9.4.2, 9.4.2.1, and 9.4.3. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1697-2017%22
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