FDA-Device2016-08-24Class II
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Merge Healthcare, Inc.
Hazard
Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
Sold states
Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
Affected count
146 sites may have the affected version for both products
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2532-2016Don't want to check this manually?
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