Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software

Recalled August 10, 2016 · FDA recall Z-2303-2016 · Merge Healthcare

Hazard

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. · FDA Class II

Units

208 sites have the affected versions

Sold at

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

Description

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.

Product

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.

Manufacturer(s)

Merge Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →