FDA Device recall Z-1496-2017
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI
- FDA Device
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI by Merge Healthcare, citing for sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same pat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1496-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-22 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | GA, IL, MD, MI, MO, OH, TN, VT |
Product
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Reason
For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.
Identifiers
| code_info | Versions 8.30, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2025-09-10 · Merge Healthcare - Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1496-2017%22
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