15
Feb
2017

Merge RadSuite software Cl II

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 2/152017
Class lI:

PRODUCT

Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recall Number Z-1180-2017

REASON
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 11/17/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8 sites have the potentially affected version

DISTRIBUTION
US Distribution was made to medical facilities in AL, IN, MI, PA and WI.

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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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