Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3105-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 14, 2017

Date Posted: September 13, 2017

Recall Number: Z-3105-2017

Event ID: 77811

Reason for Recall:

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

Status: Terminated

Product Quantity: 98 sites have the potentially affected software

Code Information:

Software versions 10.0, 10.0.1, 10.0.2, 10.0.3, 10.0.4, 10.0.5, 11.0, 11.0.1, 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1, 11.1.1.1, 11.1.1 Patch 2, 11.1.1 Patch 3, 11.1.2, 11.1.2 Patch 1, 11.1.2 Patch 2, 11.1.2 Patch 3, and 11.1.2 Patch 4. Only customers with one of the above listed software versions AND a license for Mammo Tracking are impacted by this recall.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated