Fujifilm Medical Systems U.S.A., Inc. recalls
Every recall we track for Fujifilm Medical Systems U.S.A., Inc. — 18 in all, from 2017–2021 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Fujifilm Medical Systems U.S.A., Inc. peaked in 2017 (8); 18 since 2017.
All FDA recall records for Fujifilm Medical Systems U.S.A., Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 2 | 6 | 0 | 8 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 1 | 1 | 0 | 2 |
| 2020 | 0 | 0 | 5 | 0 | 5 |
| 2021 | 0 | 0 | 3 | 0 | 3 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Fujifilm Medical Systems U.S.A., Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Fujifilm Medical Systems U.S.A., Inc. recalls
14 shown- Lower riskMedical device
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
Fujifilm recalls Synapse Cardiovascular software versions 6.0 to 6.2.1 due to potential patient ID reuse during database merges, which could lead to misidentification in medical records.
Fujifilm Medical SystemsApr 30, 2021 - Lower riskMedical device
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
Fujifilm recalls Synapse PACS software versions 5.1 to 5.7.200 due to potential display of incorrect patient information in radiology systems.
Fujif: Medical SystemsMar 2, 2021 - Lower riskMedical device
Fujifilm Medical Systems U.S.A., Inc. recalls ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Fujifilm Medical Systems recalls specific Wako TASWako i30 Chip Cassette units that may cause incorrect DCP and AFP-L3% measurements when used for certain tests.
Fujifilm Medical SystemsFeb 18, 2021 - Lower riskMedical device
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
Fujifilm recalls Wako HDL-C/LDL-C Calibrator (Lot EL62:9) due to incorrect concentration values on labels, which may lead to inaccurate cholesterol test results. Affected units should be checked for the specific lot number.
FujifilmDec 22, 2020 - Lower riskMedical device
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
Fujifilm recalls PACS software versions 7.0.0 and 7.0.1 due to clinical reporting errors when ventricular traces are changed by different users. Affected users should check their software version and contact Fujifilm for updates.
FujifilmDec 11, 2020 - Lower riskMedical device
Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS Software Versions 5.1 and higher
Fujifilm recalls Synapse PACS software versions 5.1 and higher due to risk of displaying incorrect patient information or SUV values in medical imaging. Affected users should contact the manufacturer for updates.
Fujifilm Medical SystemsSep 11, 2020 - Lower riskMedical device
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
Fujifilm recalls Synapse PACS Software Version 5.6.1 due to potential over-reporting of 3D Sphere MAX values in CT studies. Affected users should contact Fujifilm for guidance.
FujifilmSep 11, 2020 - Lower riskMedical device
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
Fujifilm recalls specific versions of Synapse PACS software (5.5.x and 5.7.x) due to potential incorrect 3D Tomo slider bar markers, which could lead to misdiagnosis. Affected units have unique serial numbers listed.
FujifilmMay 22, 2020 - Lower riskMedical device
Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm FDR Go Plus mobile X-ray system
Fujifilm recalls FDR Go Plus mobile X-ray systems due to potential Blue Screen of Death errors. Affected units have all serial numbers.
FujifilmJul 19, 2019 - Use cautionMedical device
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
Fujifilm recalls FDR Go PLUS mobile X-ray systems with serial numbers MQ0001281001 to MQ00012: The braking mechanism may not engage when the handle is released, potentially causing unintended movement during use.
Fujifilm Medical SystemsJan 15, 2019 - Lower riskMedical device
Fujifilm Medical Systems U.S.A., Inc. recalls Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite
Fujifilm recalls mammography software that may assign duplicate image IDs, causing overwritten images in PACS systems. Affected units include specific software versions of the FCRMS system.
Fujifilm Medical SystemsAug 4, 2017 - Lower riskMedical device
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
Fujifilm Medical Systems recalls ED-530XT endoscopy devices due to potential inadequate reprocessing risks. All units are affected; replacement of parts and new manual issued.
Fujif: Medical SystemsJul 21, 2017 - Lower riskMedical device
Fujifilm Medical Systems U.S.A., Inc. recalls ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR
Fujifilm recalls ASPIRE Cristalle mammography machines with serial numbers 76221095 or earlier due to risk of unintended swivel arm movement during operation. Affected units may require repair or replacement.
FujifilmJul 14, 2017 - Use cautionMedical device
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
Fujifilm recalls FDR Visionary Suite X-ray systems with CH-200 model due to potential cracks in the tube holding shaft that could lead to injury. Affected units have specific serial numbers and UDI codes.
Fujifilm Medical SystemsJun 15, 2017
Fujifilm Medical Systems U.S.A., Inc. recall questions
How many recalls has Fujifilm Medical Systems U.S.A., Inc. had?
18 recalls from Fujifilm Medical Systems U.S.A., Inc. are on record with U.S. safety agencies, from 2017–2021.
What is the most recent Fujifilm Medical Systems U.S.A., Inc. recall?
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, dated Apr 30, 2021. Every Fujifilm Medical Systems U.S.A., Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Fujifilm Medical Systems U.S.A., Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Fujifilm Medical Systems U.S.A., Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.