Fujifilm Medical Systems U.S.A., Inc. Recalls

All product recalls associated with Fujifilm Medical Systems U.S.A., Inc..

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Recall Summary

Total Recalls

9

Past Year

0

Class I (Serious)

0

Most Recent

Apr 2021

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

Fujifilm Medical Systems U.S.A., Inc.: Synapse Cardiovascular (Synapse CV). Software Versions: ...

Laceration Risk

Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence

FDAApr 30, 2021Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc.: Synapse PACS - Radiological Image Processing System - Pro...

The wrong patient information may be displayed in the viewer or PowerJacket.

FDAMar 2, 2021Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc.: TASWako Chip Cassette is part of the Wako TASWako i30 kit

Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

FDAFeb 18, 2021CA, LA, MN +3 more• Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc.: Wako HDL-C/LDL-C Calibrator - Product Usage: designed to ...

FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.

FDADec 22, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc.: FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 ...

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.

FDADec 11, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc.: Synapse PACS Software Version 5.6.1 - Product Usage: inte...

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.

FDASep 11, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc.: Synapse PACS Software Versions 5.1 and higher

There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.

FDASep 11, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc.: Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- ...

Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis

FDAMay 22, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc.: Fujifilm FDR Go Plus mobile X-ray system

The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)

FDAJul 19, 2019Nationwide• Fujifilm Medical Systems U.S.A., Inc.

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