Fujifilm Medical Systems U.S.A., Inc.
37 recalls on record · Latest: Jun 9, 2021
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Agency notice ledger
Federal filing book Fujifilm Medical Systems U.… MID-BOOK · SINGLE-AGENCY
#458 of 14,151 · 37 notices · 0.035% archive
- BOOK 37 notices
- RANK #458 of 14,151
- SHARE 0.035% archive
- AGENCY FDA Devices (37)
- CAT medical devices
- CATS 1 category
- LATEST Jun 9, 2021
- PHOTO Abbott Vascular
Nearest notice-volume peer: Abbott Vascular (0 notice gap)
Fujifilm Medical Systems U.S.A., Inc. accounts for about 0.035% of the 104,423-notice archive on 37 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
How Fujifilm Medical Systems U.… compares to 14,151 recalling firms
Fujifilm Medical Systems U.S.A., Inc. ranks 458th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Fujifilm Medical Systems U.… vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
37 458th of 14151 higher than 13,687 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Fujifilm Medical Systems U.… in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Fujifilm Medi… (this)
Fujifilm Medical Systems U.S.A., Inc.
37 notices
- Abbott Vascul…
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37 notices
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37 notices
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37 notices
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Direct Rx
37 notices
What this shows Fujifilm Medical Systems U.S.A., Inc. holds about 0.035% of archive notices alongside 37 distinct filings.
FDA Devices Moderate Jun 9, 2021
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
FDA Devices Moderate Apr 21, 2021
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
FDA Devices Moderate Apr 14, 2021
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).
FDA Devices Low Feb 3, 2021
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.
FDA Devices Moderate Feb 3, 2021
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.
FDA Devices Moderate Jan 27, 2021
Synapse PACS Software Versions 5.1 and higher
FDA Devices Moderate Oct 28, 2020
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.
FDA Devices Moderate Jul 8, 2020
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
FDA Devices Moderate Sep 11, 2019
Fujifilm FDR Go Plus mobile X-ray system
FDA Devices Moderate Mar 27, 2019
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)>
FDA Devices Moderate Feb 28, 2018
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 tr
FDA Devices Moderate Feb 28, 2018
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.
FDA Devices Moderate Feb 28, 2018
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.
FDA Devices Moderate Feb 28, 2018
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.
FDA Devices Moderate Jan 24, 2018
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.
FDA Devices Moderate Jan 24, 2018
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 m
FDA Devices Moderate Dec 20, 2017
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.
FDA Devices Moderate Oct 4, 2017
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.
FDA Devices Moderate Sep 20, 2017
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.
FDA Devices Moderate Sep 20, 2017
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.
FDA Devices Moderate Jul 19, 2017
Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
FDA Devices Moderate Oct 19, 2016
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
FDA Devices Moderate Sep 7, 2016
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.
FDA Devices Moderate Jun 29, 2016
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.
FDA Devices Moderate Jun 8, 2016
Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
FDA Devices Moderate Jun 8, 2016
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
FDA Devices Moderate Jun 8, 2016
Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
FDA Devices Moderate Jun 8, 2016
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
FDA Devices Moderate Jun 8, 2016
Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
FDA Devices Moderate May 11, 2016
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
FDA Devices Moderate Dec 23, 2015
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
FDA Devices Moderate Sep 30, 2015
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
FDA Devices Moderate Sep 30, 2015
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
FDA Devices Moderate Sep 23, 2015
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
FDA Devices Moderate May 20, 2015
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
FDA Devices Moderate May 20, 2015
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
FDA Devices Moderate May 13, 2015
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
Fujifilm Medical Systems U.… holds a measurable archive slice
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (37 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Fujifilm Medical Systems U.…? ▼
PlainRecalls indexes 37 distinct federal recall events naming Fujifilm Medical Systems U.S.A., Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Fujifilm Medical Systems U.… sit among other recalling firms? ▼
Fujifilm Medical Systems U.S.A., Inc. ranks #458 of 14,151 by distinct recall-event count among 14,151 firms in this archive (97th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Fujifilm Medical Systems U.…'s notices? ▼
FDA Devices accounts for 37 of this firm's 37 indexed notices.
What product category dominates Fujifilm Medical Systems U.…'s filing book? ▼
Filings for Fujifilm Medical Systems U.S.A., Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Fujifilm Medical Systems U.S.A., Inc.: 37 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Fujifilm Medical Systems U.S.A., Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026