Home / Recalls / Fujifilm Medical Systems U.S.A., Inc. / Z-0918-2021

Z-0918-2021 Class II Terminated

Recalled by Fujifilm Medical Systems U.S.A., Inc. — Lexington, MA

Recall Details

Product Type
Devices
Report Date
February 3, 2021
Initiation Date
December 11, 2020
Termination Date
November 17, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product 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.

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution in the state of MD.

Code Information

Versions 7.0.0 and 7.0.1

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  • Z-0282-2021 Class II — Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web b (September 11, 2020)
  • Z-2471-2020 Class II — Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface t (May 22, 2020)
  • Z-2441-2019 Class II — Fujifilm FDR Go Plus mobile X-ray system (July 19, 2019)
  • Z-1040-2019 Class II — Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is int (January 15, 2019)
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