Merge Healthcare, Inc. recalls iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, re…

Recall date

January 30, 2016

Source

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

Recall number

Z-2532-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.

Why it was recalled

Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.

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 Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.