Merge Healthcare, Inc. recalls Merge RadSuite software. Radiological image processing system.

Recall date

April 9, 2015

Source

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

Recall number

Z-2715-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.

Why it was recalled

When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.

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 RadSuite software. Radiological image processing system.