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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