FDA-Device2017-04-05Class II
iConnect Enterprise Archive (ICEA) software. 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
The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to Canada, Belgium, Australia, Jordan, and the UK..
Affected count
298 sites potentially have the affected versions (290 of those in US)
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
iConnect Enterprise Archive (ICEA) software. 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-1697-2017Don't want to check this manually?
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