Merge Healthcare, Inc. recalls Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive cli…

Recall date

March 28, 2016

Source

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

Recall number

Z-0729-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct 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 Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.