# FDA recall Z-0289-2021

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2017-01-23.

## 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.

## Distribution

Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.

## Key facts

- **Recall number:** Z-0289-2021
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-01-23
- **Report date:** 2020-11-04
- **Termination date:** 2021-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hartland, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0289-2021

## Citation

> AI Analytics. FDA recall Z-0289-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0289-2021. Source: US FDA. Licensed CC0.

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