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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2021%22
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