Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2303-2016)

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. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Product Classification:

Class II

Date Initiated: January 30, 2016

Date Posted: August 10, 2016

Recall Number: Z-2303-2016

Event ID: 74651

Reason for Recall:

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

Status: Terminated

Product Quantity: 208 sites have the affected versions

Code Information:

Versions: V6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6.0, 6.6.1, 6.6.1.1, 6.6.2

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated