medical Class II Updated 2020-10-28

Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS Software Version 5.6.1 - Product Usage: intende

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Synapse Software Version 5.6.1
View official government recall

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