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..

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