Cl II Merge iConnect Enterprise Archive software

Company: Merge Healthcare, Inc.
Date of Enforcement Report 4/5/2017
Class lI:

PRODUCT

iConnect Enterprise Archive software
Recall Number Z-1700-2017

REASON
The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.

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

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

DISTRIBUTION
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.

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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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15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.