Merge LIS — Class II medical device recall Z-0289-2021
Terminated recall by Merge Healthcare, Inc., reported 2020-11-04, distributed in AL, CA, CO, CT, FL, GA, IL, KY…. A defect in the software resulted in medications that are not associated with the patient (i.e., medications t
| Recall number | Z-0289-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2017-01-23 |
| Classified | 2020-10-23 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2021-05-01 |
| Distributed | AL, CA, CO, CT, FL, GA, IL, KY, LA, MD, MI, MS, OK, TN, TX |
| Quantity | 47 units |
| Reason classes | software |
Product
Merge LIS
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0289-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.