# FDA recall Z-3105-2017

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2017-08-14.

## Product

Merge Unity software, formerly known as DR Systems Unity PACS software.  The firm name on the label is Merge Healthcare, Hartland, WI.  Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems

## Reason for recall

The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-3105-2017
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-14
- **Report date:** 2017-09-13
- **Termination date:** 2019-05-08

- **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-3105-2017

## Citation

> AI Analytics. FDA recall Z-3105-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-3105-2017. Source: US FDA. Licensed CC0.

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