FDA Device recall Z-1180-2017
Merge RadSuite software
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of Merge RadSuite software by Merge Healthcare, citing the values provided from the Pixel Value tool do not appear to be correct, 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-1180-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-17 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | AL, IN, MI, PA, WI |
Product
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Identifiers
| code_info | Version V8.30.7.8 |
|---|
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-1180-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.