FDA Device recall Z-2685-2016
RadSuite software
- FDA Device
- Class II
- terminated
- Published 2016-09-07
On 2016-09-07 the FDA classified a Class II recall of RadSuite software by Merge Healthcare, citing interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2685-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-30 |
| Published | 2016-09-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | CO, OK |
Product
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
Reason
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Identifiers
| code_info | Versions V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2685-2016%22
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