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

Recall date

May 24, 2017

Source

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

Recall number

Z-2601-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.

Why it was recalled

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

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