FDA-Device2016-10-26Class II
Fusion Workstation.; Indicated for the transmission and review of radiological images.
Merge Healthcare, Inc.
Hazard
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
Sold states
Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
Affected count
13 sites potentially hae the affected version
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Fusion Workstation.; Indicated for the transmission and review of radiological images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0294-2017Don't want to check this manually?
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