Home / Recalls / Fujifilm Medical Systems U.S.A., Inc. / Z-0282-2021

Z-0282-2021 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
October 28, 2020
Initiation Date
September 11, 2020
Termination Date
November 17, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution including in the state of Minnesota.

Code Information

Synapse Software Version 5.6.1

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  • Z-0932-2021 Class III — Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Typ (December 22, 2020)
  • Z-0918-2021 Class II — FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: inten (December 11, 2020)
  • Z-0878-2021 Class II — Synapse PACS Software Versions 5.1 and higher (September 11, 2020)
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  • Z-2441-2019 Class II — Fujifilm FDR Go Plus mobile X-ray system (July 19, 2019)
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