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Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Medical Systems U.S.A., Inc.: 37 FDA recall reports
Every medical device recall the FDA has published for Fujifilm Medical Systems U.S.A., Inc.. The fault, and how the agency graded it.
37Reports
0Class I
3Ongoing
2021-06-09Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a
Z-1775-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- 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
- Product
- Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
- How much
- 44 US and 4 OUS
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Z-1412-2021 · Class II · reported 2021-04-21 · Terminated
- Why it was recalled
- Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
- Product
- ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
- Where it went
- CA, LA, MN, NC, UT, WI
- How much
- 496 units
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based applicat
Z-1348-2021 · Class II · reported 2021-04-14 · Ongoing
- Why it was recalled
- The wrong patient information may be displayed in the viewer or PowerJacket.
- Product
- Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Belgium, Bermuda, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Czechia, Germany, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Israel, India, Italy, Jordan, Japan, Kuwait, Malta, Mexico, Malaysia, Netherlands, Peru, Philippines, Pakistan, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Turkey, Uruguay, South Africa, Zimbabwe.
- How much
- 839 systems
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for th
Z-0932-2021 · Class III · reported 2021-02-03 · Terminated
- Why it was recalled
- 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.
- Product
- 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 determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.
- Where it went
- US Nationwide distribution including in the states of MO, OR, MD, PA.
- How much
- 10 boxes (4 units per box)
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based app
Z-0918-2021 · Class II · reported 2021-02-03 · Terminated
- Why it was recalled
- 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.
- Product
- FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - 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.
- Where it went
- US Nationwide distribution in the state of MD.
- How much
- 1 unit
Synapse PACS Software Versions 5.1 and higher
Z-0878-2021 · Class II · reported 2021-01-27 · Ongoing
- Why it was recalled
- 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.
- Product
- Synapse PACS Software Versions 5.1 and higher
- Where it went
- Software was distributed to medical facilities nationwide throughout the U.S.
- How much
- 235
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the
Z-0282-2021 · Class II · reported 2020-10-28 · Terminated
- Why it was recalled
- 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.
- Product
- 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.
- Where it went
- US Nationwide distribution including in the state of Minnesota.
- How much
- 1
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS So
Z-2471-2020 · Class II · reported 2020-07-08 · Ongoing
- Why it was recalled
- 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
- Product
- Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
- Where it went
- Nationwide
- How much
- 135 units
Fujifilm FDR Go Plus mobile X-ray system
Z-2441-2019 · Class II · reported 2019-09-11 · Terminated
- Why it was recalled
- The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
- Product
- Fujifilm FDR Go Plus mobile X-ray system
- Where it went
- Nationwide
- How much
- 174 units
Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a fil
Z-1040-2019 · Class II · reported 2019-03-27 · Terminated
- Why it was recalled
- 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.
- Product
- Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>
- Where it went
- US Nationwide Distribution
- How much
- 56 units
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammogr
Z-0662-2018 · Class II · reported 2018-02-28 · Terminated
- Why it was recalled
- 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.
- Product
- Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.
- Where it went
- Worldwide Distribution.
- How much
- 71 units (68 units Domestic. 3 units Foreign) in total
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500)
Z-0661-2018 · Class II · reported 2018-02-28 · Terminated
- Why it was recalled
- 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.
- Product
- ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
- Where it went
- Worldwide Distribution.
- How much
- 71 units (68 units Domestic. 3 units Foreign) in total
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FD
Z-0660-2018 · Class II · reported 2018-02-28 · Terminated
- Why it was recalled
- 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.
- Product
- Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
- Where it went
- Worldwide Distribution.
- How much
- 71 units (68 units Domestic. 3 units Foreign) in total
Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates ful
Z-0659-2018 · Class II · reported 2018-02-28 · Terminated
- Why it was recalled
- 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.
- Product
- Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
- Where it went
- Worldwide Distribution.
- How much
- 71 units (68 units Domestic. 3 units Foreign) in total
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plu
Z-0386-2018 · Class II · reported 2018-01-24 · Terminated
- Why it was recalled
- There was a case that the swivel arm went down unintentionally when it was moved up/down.
- Product
- ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
- Where it went
- US Distribution and Internationally to Mexico.
- How much
- 15 US 1 OUS
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as A
Z-0385-2018 · Class II · reported 2018-01-24 · Terminated
- Why it was recalled
- There was a case that the swivel arm went down unintentionally when it was moved up/down.
- Product
- 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 Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
- Where it went
- US Distribution and Internationally to Mexico.
- How much
- 20 US
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) Th
Z-0232-2018 · Class II · reported 2017-12-20 · Terminated
- Why it was recalled
- 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.
- Product
- FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
- Where it went
- US Distribution.
- How much
- 3
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract,
Z-3225-2017 · Class II · reported 2017-10-04 · Terminated
- Why it was recalled
- 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.
- Product
- FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
- Where it went
- Nationwide
- How much
- 362 units
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is
Z-3129-2017 · Class II · reported 2017-09-20 · Terminated
- Why it was recalled
- Fujifilm is conducting a corrective action due to an FDA inspection.
- Product
- Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
- Where it went
- US Nationwide Distribution
- How much
- 260 manuals in total
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum
Z-3128-2017 · Class II · reported 2017-09-20 · Terminated
- Why it was recalled
- Fujifilm is reporting a corrective action due to an FDA inspection.
- Product
- Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
- Where it went
- US Nationwide Distribution
- How much
- 260 manuals in total
Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic
Z-2706-2017 · Class II · reported 2017-07-19 · Terminated
- Why it was recalled
- Fujifilm is recalling multiple endoscopes after a retrospective review.
- Product
- Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
- Where it went
- US Distribution to : AL, HI and MO
- How much
- 4 units
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imagi
Z-0073-2017 · Class II · reported 2016-10-19 · Terminated
- Why it was recalled
- Image data for a patients image may not be correct
- Product
- Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
- Where it went
- US Nationwide Distribution.
- How much
- 251 units
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifi
Z-2690-2016 · Class II · reported 2016-09-07 · Terminated
- Why it was recalled
- If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
- Product
- FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
- Where it went
- US Distribution to: NC and HI.
- How much
- 2 Units
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Syn
Z-2043-2016 · Class II · reported 2016-06-29 · Terminated
- Why it was recalled
- Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
- Product
- Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.
- Where it went
- US Distribution to states of: CA, FL, KS, NE, NY, and PA.
- How much
- 27 units
Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Z-1861-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Product
- Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
- Where it went
- Nationwide Distribution.
- How much
- 98 units
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Z-1864-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Product
- Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
- Where it went
- Nationwide Distribution.
- How much
- 94 units
Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
Z-1862-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Product
- Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
- Where it went
- Nationwide Distribution.
- How much
- 882 units
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Z-1860-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Product
- Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
- Where it went
- Nationwide Distribution.
- How much
- 1473 units
Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
Z-1863-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Product
- Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
- Where it went
- Nationwide Distribution.
- How much
- 484 units
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Z-1599-2016 · Class II · reported 2016-05-11 · Terminated
- Why it was recalled
- Reports of failure of the device's power supply.
- Product
- Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
- Where it went
- Nationwide Distribution.
- How much
- 2,062 devices
Showing the 30 most recent of 37. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls