07
Sep
2016

Merge RadSuite software Cl II

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 9/7/2016
Class lI:

PRODUCT

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
Recall Number Z-2685-2016

REASON
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 8/29/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
96 sites potentially have the affected versions for both products

DISTRIBUTION
US Distribution to: CO and OK.

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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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