FDA-Device2017-03-22Class II
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
Merge Healthcare, Inc.
Hazard
The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
Sold states
USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.
Affected count
187 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1470-2017Don't want to check this manually?
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