FDA-Device2017-02-15Class II
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Hazard
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.
Sold states
US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
Affected count
8 sites have the potentially affected version
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1180-2017Don't want to check this manually?
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