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

37 recalls on record · latest: April 30, 2021

Official U.S. recall history for Fujifilm Medical Systems U.S.A., Inc., compiled from official government records.

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Fujifilm Medical Systems U.S.A., Inc. recalls Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management a…

April 30, 2021 · Medical device recalls Moderate risk Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a p…

Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on a…

March 2, 2021 · Medical device recalls Moderate risk The wrong patient information may be displayed in the viewer or PowerJacket.

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

February 18, 2021 · Medical device recalls Moderate risk Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measure…

Fujifilm Medical Systems U.S.A., Inc. recalls Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determi…

December 22, 2020 · Medical device recalls FUJIFILM has become aware that incorrect concentration values were printed on t…

Fujifilm Medical Systems U.S.A., Inc. recalls FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application o…

December 11, 2020 · Medical device recalls Moderate risk The software does not update measurements and calculations in the Clinical Repo…

Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC…

September 11, 2020 · Medical device recalls Moderate risk FUJIFILM has become aware of the possibility that certain CT studies may report…

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

September 11, 2020 · Medical device recalls Moderate risk There is a potential for the wrong patient information may be displayed in the…

Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Se…

May 22, 2020 · Medical device recalls Moderate risk Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be dis…

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

July 19, 2019 · Medical device recalls Moderate risk The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Scr…

Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or gener…

January 15, 2019 · Medical device recalls Moderate risk FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the pos…

Fujifilm Medical Systems U.S.A., Inc. recalls Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (F…

August 4, 2017 · Medical device recalls Moderate risk FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure wit…

Fujifilm Medical Systems U.S.A., Inc. recalls ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates fu…

August 4, 2017 · Medical device recalls Moderate risk FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure wit…

Fujifilm Medical Systems U.S.A., Inc. recalls Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) an…

August 4, 2017 · Medical device recalls Moderate risk FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure wit…

Fujifilm Medical Systems U.S.A., Inc. recalls Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digi…

August 4, 2017 · Medical device recalls Moderate risk FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure wit…

Fujifilm Medical Systems U.S.A., Inc. recalls FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically…

July 21, 2017 · Medical device recalls Moderate risk An update to the design and labeling was implemented to help reduce patient ris…

Fujifilm Medical Systems U.S.A., Inc. recalls ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-250…

July 14, 2017 · Medical device recalls Moderate risk There was a case that the swivel arm went down unintentionally when it was move…

Fujifilm Medical Systems U.S.A., Inc. recalls Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plu…

July 14, 2017 · Medical device recalls Moderate risk There was a case that the swivel arm went down unintentionally when it was move…

Fujifilm Medical Systems U.S.A., Inc. recalls FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Vision…

June 15, 2017 · Medical device recalls Moderate risk A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the D…

Fujifilm Medical Systems U.S.A., Inc. recalls Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of sub…

February 17, 2017 · Medical device recalls Moderate risk Fujifilm is recalling multiple endoscopes after a retrospective review.

Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and inform…

September 15, 2016 · Medical device recalls Moderate risk Image data for a patients image may not be correct

Fujifilm Medical Systems U.S.A., Inc. recalls FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital M…

June 9, 2016 · Medical device recalls Moderate risk If an exposure is aborted during a stereo biopsy workflow, an error may occur w…

Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS s…

May 10, 2016 · Medical device recalls Moderate risk Synapse cannot display image files, DICOM SR files, and/or Annotation files. Th…

Fujifilm Medical Systems U.S.A., Inc. recalls Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

April 1, 2016 · Medical device recalls Moderate risk Reports of failure of the device's power supply.