Merge Healthcare, Inc. recalls iConnect Enterprise Archive software.

Recall date

April 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1700-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.

Why it was recalled

The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

iConnect Enterprise Archive software.