FDA Device recall Z-2865-2016
Merge Cardio software
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of Merge Cardio software by Merge Healthcare, citing patient information in the header is only found on the first page of the report and not on the subsequent pages.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2865-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-30 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Reason
Patient information in the header is only found on the first page of the report and not on the subsequent pages.
Identifiers
| code_info | Version 10.1 |
|---|
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-2865-2016%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.