FDA Device recall Z-2363-2016
Merge PACS software
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Merge PACS software by Merge Healthcare, citing when measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements ar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2363-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-05 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | n/a |
Product
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Reason
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
Identifiers
| code_info | Software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1 |
|---|
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-2363-2016%22
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