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Recall Observatory FDA recall evidence

Device product

FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - 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-0918-2021

December 11, 2020

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 87083
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0918-2021

Official wording

Reason: The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.

Code information: Versions 7.0.0 and 7.0.1

Distribution pattern: US Nationwide distribution in the state of MD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.