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Fujifilm Medical Systems U.S.A Recalls
37 recalls on record · May 13, 2015 to June 9, 2021 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 9, 2021Medical DevicesFDA
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
Hazard: 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
April 21, 2021Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Hazard: Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
April 14, 2021Medical DevicesFDA
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 an
Hazard: The wrong patient information may be displayed in the viewer or PowerJacket.
February 3, 2021Medical DevicesFDA
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 determin
Hazard: 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.
February 3, 2021Medical DevicesFDA
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
Hazard: 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.
January 27, 2021Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS Software Versions 5.1 and higher
Hazard: 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.
October 28, 2020Medical DevicesFDA
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
Hazard: 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.
July 8, 2020Medical DevicesFDA
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
Hazard: 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
September 11, 2019Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm FDR Go Plus mobile X-ray system
Hazard: The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
March 27, 2019Medical DevicesFDA
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 g
Hazard: FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.
February 28, 2018Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite
Hazard: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
February 28, 2018Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates
Hazard: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
February 28, 2018Medical DevicesFDA
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)
Hazard: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
February 28, 2018Medical DevicesFDA
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 di
Hazard: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
January 24, 2018Medical DevicesFDA
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-
Hazard: There was a case that the swivel arm went down unintentionally when it was moved up/down.
January 24, 2018Medical DevicesFDA
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 P
Hazard: There was a case that the swivel arm went down unintentionally when it was moved up/down.
December 20, 2017Medical DevicesFDA
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 Visi
Hazard: A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
October 4, 2017Medical DevicesFDA
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, specifical
Hazard: An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
September 20, 2017Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical
Hazard: Fujifilm is conducting a corrective action due to an FDA inspection.
September 20, 2017Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper
Hazard: Fujifilm is reporting a corrective action due to an FDA inspection.
July 19, 2017Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of
Hazard: Fujifilm is recalling multiple endoscopes after a retrospective review.
October 19, 2016Medical DevicesFDA
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 inf
Hazard: Image data for a patients image may not be correct
September 7, 2016Medical DevicesFDA
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
Hazard: If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
June 29, 2016Medical DevicesFDA
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
Hazard: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
June 8, 2016Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Hazard: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
June 8, 2016Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
Hazard: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
June 8, 2016Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
Hazard: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
June 8, 2016Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Hazard: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
June 8, 2016Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Hazard: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
May 11, 2016Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Hazard: Reports of failure of the device's power supply.