29

Mar

2017

Cl II Merge Cardio software.

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/29/2017
Class lI:

PRODUCT

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..
Recall Number Z-1517-2017

REASON
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.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 9/22/2015. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
89 sites potentially have the affected accessory

DISTRIBUTION
Nationwide sites.. Military distribution was also made. There was no foreign/government distribution.

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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