Fujifilm Medical Systems U.S.A., Inc.
24 recalls on record · Latest: Apr 21, 2021
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