31
Aug
2016

Merge RadSuite software Cl II

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/31/2016
Class lI:

PRODUCT

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recall Number Z-2627-2016

REASON
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc, Hartland, WI on 8/23/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
25 sites have the affected version

DISTRIBUTION
Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.

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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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