Merge Healthcare, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2063-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1

Product Classification:

Class II

Date Initiated: July 11, 2019

Date Posted: July 31, 2019

Recall Number: Z-2063-2019

Event ID: 83300

Reason for Recall:

Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

Status: Terminated

Product Quantity: 73 devices

Code Information:

Version 7.3 (UDI Number (01)00842000100706(10)7.3.0.158618(11)180409); 7.3.1 (UDI Number (01)00842000100706(10)7.3.1.161404(11)180830); 8.0 (UDI Number (01)00842000100775(10)8.0.0.162051(11)181026); 8.0.1 (UDI Number (01)00842000100775(10)8.0.1.165704(11)190528)

Distribution Pattern:

Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated