Merge Healthcare, Inc. recalls Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer,…

Recall date

September 22, 2015

Source

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

Recall number

Z-1517-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US Nationwide Distribution.

Why it was recalled

Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.

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. Product Usage: 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.