Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1385-2017)

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:

DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS 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: April 8, 2016

Date Posted: March 8, 2017

Recall Number: Z-1385-2017

Event ID: 76471

Reason for Recall:

The software is not adding the correct tomo image.

Status: Terminated

Product Quantity: 28 sites potentially have the affected software

Code Information:

Versions 11.0 and 11.0.1

Distribution Pattern:

US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated