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

Complete recall history across all FDA and CPSC categories, 37 total recalls

Fujifilm Medical Systems U.S.A., Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (37)

FDA medical device enforcement actions by Fujifilm Medical Systems U.S.A., Inc.

Date Product Reason Class
Apr 30, 2021 Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The S... Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a... Class II
Mar 2, 2021 Synapse PACS - Radiological Image Processing System - Product Usage: intended... The wrong patient information may be displayed in the viewer or PowerJacket. Class II
Feb 18, 2021 ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measu... Class II
Dec 22, 2020 Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-... FUJIFILM has become aware that incorrect concentration values were printed on... Class III
Dec 11, 2020 FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: in... The software does not update measurements and calculations in the Clinical Re... Class II
Sep 11, 2020 Synapse PACS Software Versions 5.1 and higher There is a potential for the wrong patient information may be displayed in th... Class II
Sep 11, 2020 Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a we... FUJIFILM has become aware of the possibility that certain CT studies may repo... Class II
May 22, 2020 Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interfac... Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be d... Class II
Jul 19, 2019 Fujifilm FDR Go Plus mobile X-ray system The graphics driver of the FDR Go PLUS might cause the appearance of a Blue S... Class II
Jan 15, 2019 Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is ... FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the p... Class II
Aug 4, 2017 Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspir... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure w... Class II
Aug 4, 2017 Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammog... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure w... Class II
Aug 4, 2017 ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography Syste... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure w... Class II
Aug 4, 2017 Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The ... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure w... Class II
Jul 21, 2017 FUJINON ED-530XT. This device is intended for the visualization of the duo... An update to the design and labeling was implemented to help reduce patient r... Class II
Jul 14, 2017 Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s... There was a case that the swivel arm went down unintentionally when it was mo... Class II
Jul 14, 2017 ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital M... There was a case that the swivel arm went down unintentionally when it was mo... Class II
Jun 15, 2017 FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary ... A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the... Class II
Feb 17, 2017 Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscop... Fujifilm is recalling multiple endoscopes after a retrospective review. Class II
Sep 15, 2016 Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx,... Image data for a patients image may not be correct Class II
Jun 9, 2016 FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Posit... If an exposure is aborted during a stereo biopsy workflow, an error may occur... Class II
May 10, 2016 Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS softwa... Synapse cannot display image files, DICOM SR files, and/or Annotation files.... Class II
Apr 1, 2016 Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU Reports of failure of the device's power supply. Class II
Dec 23, 2015 Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant ... Class II
Dec 23, 2015 Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleani... This correction is in response to publicized reports of multi-drug resistant ... Class II
Dec 23, 2015 Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant ... Class II
Dec 23, 2015 Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant ... Class II
Dec 23, 2015 Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection This correction is in response to publicized reports of multi-drug resistant ... Class II
Aug 31, 2015 Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED... A precautionary measure because the Duodenoscopes have been redesigned to inc... Class II
Jun 30, 2015 Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic ... The EPX-2500 Operation Manual and sales brochure incorrectly identify that th... Class II
Jun 30, 2015 Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, E... The suction button on the ED-530XT endoscope may become lodged (stuck) in the... Class II
Jun 30, 2015 Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For... The EPX-2500 Operation Manual and sales brochure incorrectly identify that th... Class II
Mar 9, 2015 Fujifilm Endoscope Model ED-530XT Product Usage: This product is a me... Fujifilm is reporting a corrective action due to an FDA inspection. Class II
Mar 9, 2015 Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 ... Fujifilm is conducting a corrective action due to an FDA inspection. Class II
Feb 4, 2015 FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Ar... Measurement values in the EMR may not accurately reflect the actual measureme... Class II
Feb 4, 2015 Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascu... Under certain circumstances the patient Demographics in a report exported in... Class II
Feb 3, 2015 Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-10... User Manual lacks a description for handling some errors even though the sys... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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