Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display t

Recalled August 10, 2016 · FDA recall Z-2301-2016 · Merge Healthcare

Hazard

Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. · FDA Class II

Units

109 sites have the affected versions

Sold at

Worldwide Distribution -- USA, New Zealand, and United Kingdom.

Description

Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.

Product

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. 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 →