# FDA recall Z-2591-2017

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2017-05-08.

## Product

Merge PACS software.   Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography

## Reason for recall

When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician.  This may cause a misdiagnosis.

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-2591-2017
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-08
- **Report date:** 2017-06-21
- **Termination date:** 2019-08-08

- **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-2591-2017

## Citation

> AI Analytics. FDA recall Z-2591-2017. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-2591-2017. Source: US FDA. Licensed CC0.

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