FDA-Device2016-09-07Class II
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
Merge Healthcare, Inc.
Hazard
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Sold states
US Distribution to: CO and OK.
Affected count
96 sites potentially have the affected versions for both products
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2686-2016Don't want to check this manually?
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