FDA-Device2020-10-28Class II
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Fujifilm Medical Systems U.S.A., Inc.
Hazard
FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.
Sold states
US Nationwide distribution including in the state of Minnesota.
Affected count
1
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2021Don't want to check this manually?
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