FDA Device recall Z-1470-2017
iConnect Enterprise Archive when used with RadSuite
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of iConnect Enterprise Archive when used with RadSuite by Merge Healthcare, citing the software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1470-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-04 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
Reason
The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
Identifiers
| code_info | iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0. |
|---|
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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FDA Device · Class II · 2025-09-10 · Merge Healthcare - Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1470-2017%22
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