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Fujifilm Medical Systems U.S.A., Inc. Recall 87083

Description: 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.

Fujifilm Medical Systems U.S.A., Inc. Recall 87083 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0918-2021
Event ID87083
Event DescriptionFUJIFILM 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.
Product TypeDevices
DistributionUS Nationwide distribution in the state of MD.
Quantity1 unit
Recall ReasonThe 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.
Device Classification20210203
Device Code InfoVersions 7.0.0 and 7.0.1
Center Classification Date20210122
Recall Initiation Date20201211
Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Initial Notification Letter
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