Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2379-2016)

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 PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

Product Classification:

Class II

Date Initiated: January 30, 2016

Date Posted: August 17, 2016

Recall Number: Z-2379-2016

Event ID: 74773

Reason for Recall:

The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.

Status: Terminated

Product Quantity: 93 sites have the affected version

Code Information:

Versions: V6.0.2.0 MR2 and earlier

Distribution Pattern:

The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.

Voluntary or Mandated:

Voluntary: Firm initiated