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

March 28, 2016

Source

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

Recall number

Z-1046-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.

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.