Fujifilm Medical System U.S.A., Inc.
Country not established
- Devices
- 109
- FDA recalls
- 421 ongoing since 2021 (3 open in total)
At a glance
Market reach
- United States
- FDA recalls
What Fujifilm Medical System U.S.A., Inc. makes
The company manufactures digital radiography systems, including flat panel detectors (e.g., FDR ACSELERATE DR-ID 200), computed radiography (CR) consoles and image readers (e.g., FCR CLEARVIEW CS), and computed tomography (CT) analysis software (e.g., Synapse 3D for lung, abdomen, and brain perfusion imaging). It also produces laser film digitizers (e.g., Fujifilm Laser Imager Multi-Formatters MF-300/MF-300L), mammography intensifying screens (FUJI UM MAMMO series), and X-ray processing hardware (e.g., VP-7000 processor, BL-7000 light source). Additional offerings include tomosynthesis options for stationary X-ray systems and post-processing tools for 3D imaging reconstruction (e.g., Synapse Obliquus MIP/MPR/Fusion).
The portfolio includes devices regulated as Class I and Class II under FDA pathways, with submissions recorded in the 510(k) and PMA registries. The manufacturer operates from the United States.
Catalogue
Search and filter all 109 devicesShowing 1-50 of 109
FDA recalls
FDA recall records list 5 recalls initiated by Fujifilm Medical System U.S.A., Inc., the earliest on 2003-05-12 and the most recent on 2012-06-29. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 9
- 2018 0
- 2019 2
- 2020 5
- 2021 3
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 30 Apr 2021 Z-1775-2021 Class II Terminated 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
Full distribution text
- 2 Mar 2021 Z-1348-2021 Class II Ongoing The wrong patient information may be displayed in the viewer or PowerJacket.
Full distribution text
- 18 Feb 2021 Z-1412-2021 Class II Terminated Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
- 30 Apr 2021 Z-1775-2021 Class II Terminated 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
2020
- 22 Dec 2020 Z-0932-2021 Class III Terminated 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.
- 11 Dec 2020 Z-0918-2021 Class II Terminated 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.
- 11 Sep 2020 Z-0282-2021 Class II Terminated 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.
- 11 Sep 2020 Z-0878-2021 Class II Open since 2020 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.
- 22 May 2020 Z-2471-2020 Class II Open since 2020 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
2019
- 19 Jul 2019 Z-2441-2019 Class II Terminated The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
- 15 Jan 2019 Z-1040-2019 Class II Terminated 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.
Show the 25 most recent of 42 recalls
2017
- 4 Aug 2017 Z-0659-2018 Class II Terminated FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS 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.
- 4 Aug 2017 Z-0660-2018 Class II Terminated FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS 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.
- 4 Aug 2017 Z-0661-2018 Class II Terminated FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS 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.
- 4 Aug 2017 Z-0662-2018 Class II Terminated FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS 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.
- 21 Jul 2017 Z-3225-2017 Class II Terminated 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.
- 14 Jul 2017 Z-0385-2018 Class II Terminated There was a case that the swivel arm went down unintentionally when it was moved up/down.
- 14 Jul 2017 Z-0386-2018 Class II Terminated There was a case that the swivel arm went down unintentionally when it was moved up/down.
- 15 Jun 2017 Z-0232-2018 Class II Terminated 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.
- 17 Feb 2017 Z-2706-2017 Class II Terminated Fujifilm is recalling multiple endoscopes after a retrospective review.
2016
- 15 Sep 2016 Z-0073-2017 Class II Terminated Image data for a patients image may not be correct
- 9 Jun 2016 Z-2690-2016 Class II Terminated If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
- 10 May 2016 Z-2043-2016 Class II Terminated Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
- 1 Apr 2016 Z-1599-2016 Class II Terminated Reports of failure of the device's power supply.
2015
- 23 Dec 2015 Z-1860-2016 Class II Terminated This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- 23 Dec 2015 Z-1861-2016 Class II Terminated This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Frequently asked questions
How many devices does Fujifilm Medical System U.S.A., Inc. have in the registry?
The registry currently lists 109 devices for Fujifilm Medical System U.S.A., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fujifilm Medical System U.S.A., Inc.'s devices?
Among its 50 most recently registered devices, Fujifilm Medical System U.S.A., Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Fujifilm Medical System U.S.A., Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Fujifilm Medical System U.S.A., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fujifilm Medical System U.S.A., Inc.?
FDA recall records list 42 recalls initiated by Fujifilm Medical System U.S.A., Inc., the most recent initiated on 30 Apr 2021. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Fujifilm Medical System U.S.A., Inc. in the registry?
The most recently registered devices listed for Fujifilm Medical System U.S.A., Inc. include FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR, FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP, FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER and FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II.