Merge Unity

Version 11.0

Radiology Devices

2

No

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

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.

Version 11.0

Radiology Devices

2

No

US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.

DR Systems Unity PACS software, now known as Merge Unity PACS

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.

Radiology Devices

2

No

Nationwide Distribution

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

Version 11.0

Radiology Devices

2

No

Distribution was made to medical facilities located in MT, CA, PA, and TX.

DR Systems Unity PACS software, now known as Merge Unity PACS software.