# FDA recall Z-2387-2021

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2021-07-23.

## Product

Merge Hemo, Software packages 10.2, 10.3, and 10.4

## Reason for recall

The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.

## Distribution

US distribution

## Key facts

- **Recall number:** Z-2387-2021
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-23
- **Report date:** 2021-09-08
- **Termination date:** 2023-08-29

- **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-2387-2021

## Citation

> AI Analytics. FDA recall Z-2387-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2387-2021. Source: US FDA. Licensed CC0.

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