# FDA recall Z-3004-2026

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2026-07-22.

## Product

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

## Reason for recall

Software issue may cause measurements to be displayed inaccurately.

## Distribution

US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.

## Key facts

- **Recall number:** Z-3004-2026
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-22
- **Report date:** 2026-09-02

- **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-3004-2026

## Citation

> MORVS. FDA recall Z-3004-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-3004-2026. Source: US FDA. Licensed CC0.

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