Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2551-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems 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: July 23, 2015

Date Posted: August 24, 2016

Recall Number: Z-2551-2016

Event ID: 74846

Reason for Recall:

The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.

Status: Terminated

Product Quantity: 9 sites potentially have the affected version

Code Information:

Version 11.0

Distribution Pattern:

US Distribution to states of: CA, PA, TX, and MT.

Voluntary or Mandated:

Voluntary: Firm initiated