FDA Device recall Z-2591-2017
Merge PACS software
- FDA Device
- Class II
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class II recall of Merge PACS software by Merge Healthcare, citing when cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2591-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-08 |
| Published | 2017-06-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Reason
When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
Identifiers
| code_info | Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2 |
|---|
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-2591-2017%22
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