FDA Device recall Z-2301-2016
Merge PACS software
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of Merge PACS software by Merge Healthcare, citing studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2301-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-30 |
| Published | 2016-08-10 |
| 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, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Reason
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
Identifiers
| code_info | Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3. |
|---|
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-2301-2016%22
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