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Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC
Recalled October 28, 2020 · FDA recall Z-0282-2021 · Fujifilm Medical Systems U.S.A
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. · FDA Class II
Units
1
Sold at
US Nationwide distribution including in the state of Minnesota.
Description
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.
Product
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.
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →