FDA-Device2016-11-23Class II
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Hazard
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
Sold states
Distribution was made to medical facilities nationwide. Foreign distribution was also made.
Affected count
60 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
iConnect Access 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-0611-2017Don't want to check this manually?
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