PlainRecalls

Fujifilm Medical Systems U.S.A., Inc.

24 recalls on record · Latest: Apr 21, 2021

Fujifilm Medical Systems U.S.A., Inc. Recall Insight

Fujifilm Medical Systems U.S.A., Inc. appears on 24 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.029% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 21, 2021, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 24 entries, severity tagging shows 0 critical, 24 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 24 of 24 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (24). The date window on this page runs from May 13, 2015 to Apr 21, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Apr 21, 2021

¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit

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 minimu…

FDA Devices Moderate Sep 11, 2019

Fujifilm FDR Go Plus mobile X-ray system

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…

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 mammograp…

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…

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…

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 ge…

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 an…

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 org…

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, S…

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 H…

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 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. …

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 imag…

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 Manua…

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…

FDA Devices Moderate May 20, 2015

FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovasc…

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 c…

Nearby Manufacturers

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds