14
Sep
2016

Merge RadSuite software; Cl II

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 9/14/2016
Class lI:

PRODUCT

Merge RadSuite software. Radiological image processing system.
Recall Number Z-2715-2016

REASON
When RadSuite is used with IPID (Issuer of Patient ID) as a part of the “Patient Identifier,” it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 9/2/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
10 sites

DISTRIBUTION
AL, MI, MO, PA, TN, and TX..

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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.

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