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Recall Observatory FDA recall evidence

Device 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.

Z-0282-2021

September 11, 2020

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 86494
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0282-2021

Official wording

Reason: 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.

Code information: Synapse Software Version 5.6.1

Distribution pattern: US Nationwide distribution including in the state of Minnesota.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.