Merge Healthcare, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2566-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

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 7, 2017

Date Posted: August 8, 2018

Recall Number: Z-2566-2018

Event ID: 80570

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: 11 sites have potentially affected software

Code Information:

Software versions 10.0.6 and 10.0.7. Only customers with these 2 versions AND a license for Mammo Tracking are impacted by this recall.

Distribution Pattern:

Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.

Voluntary or Mandated:

Voluntary: Firm initiated