FDA Device recall Z-0289-2021
Merge LIS
- FDA Device
- Class II
- terminated
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of Merge LIS by Merge Healthcare, citing A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0289-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-23 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Merge Healthcare |
| Distribution | AL, CA, CO, CT, FL, GA, IL, KY, LA, MD, MI, MS, OK, TN, TX |
Product
Merge LIS
Reason
A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
Identifiers
| code_info | Merge LIS versions 4.0.1, 4.1, 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.1.5, 4.1.5 Patch 1, and 4.1.5 Patch 2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Merge Healthcare
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-09-02 · Merge Healthcare - Merge PACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCS…
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-0289-2021%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.