# FDA recall Z-2062-2019

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2019-07-11.

## Product

Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

## Reason for recall

Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled.      Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

## Distribution

Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin.      International distribution to Belgium and Canada.

## Key facts

- **Recall number:** Z-2062-2019
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-11
- **Report date:** 2019-07-31
- **Termination date:** 2023-03-17

- **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-2062-2019

## Citation

> AI Analytics. FDA recall Z-2062-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2062-2019. Source: US FDA. Licensed CC0.

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