Merge: Merge Cardio software Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 5/31/2017
Class lI:

PRODUCT

Merge Cardio software
Recall Number Z-2123-2017

REASON
Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother’s MRN, resulting in the wrong fetal measurements getting referenced.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/13/2016. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
30 sites potentially have the affected versions

DISTRIBUTION
Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.

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About the author

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Partners located in the US (CA, FL, MA, MN) and Italy.