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

Recall date

May 8, 2017

Source

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

Recall number

Z-2590-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

USA (nationwide) Distribution .There was no foreign/government/military distribution.

Why it was recalled

Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.

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