Merge Healthcare, Inc. recalls Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LI…

Recall date

January 30, 2016

Source

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

Recall number

Z-0664-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.

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

What was recalled

Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications