FDA-Device2016-10-19Class II
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Fujifilm Medical Systems U.S.A., Inc.
Hazard
Image data for a patients image may not be correct
Sold states
US Nationwide Distribution.
Affected count
251 units
Manufactured in
419 West Ave, N/A, Stamford, CT, United States
Products
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0073-2017Don't want to check this manually?
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