26
Oct
2016

Merge Fusion Workstation; Cl II

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 10/26/2016
Class lI:

PRODUCT

Fusion Workstation.; Indicated for the transmission and review of radiological images.
Recall Number Z-0294-2017

REASON
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 10/20/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
13 sites potentially have the affected versions

DISTRIBUTION
AZ, CA, ID, IL, IN, MI, MN, and NJ..

___________________________________

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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