Fujifilm Medical Systems U recalls
Fujifilm Medical Systems U appears in 37 official U.S. recall notices indexed by RecallRadar, most recently on 2021-06-09.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
FDA Device · Class II · 2021-06-09 · Fujifilm Medical Systems U - ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
FDA Device · Class II · 2021-04-21 · Fujifilm Medical Systems U - Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC m…
FDA Device · Class II · 2021-04-14 · Fujifilm Medical Systems U - 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 P…
FDA Device · Class II · 2021-02-03 · Fujifilm Medical Systems U - 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 densi…
FDA Device · Class III · 2021-02-03 · Fujifilm Medical Systems U - Synapse PACS Software Versions 5.1 and higher
FDA Device · Class II · 2021-01-27 · Fujifilm Medical Systems U - 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 exce…
FDA Device · Class II · 2020-10-28 · Fujifilm Medical Systems U - Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
FDA Device · Class II · 2020-07-08 · Fujifilm Medical Systems U - Fujifilm FDR Go Plus mobile X-ray system
FDA Device · Class II · 2019-09-11 · Fujifilm Medical Systems U - 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 pa…
FDA Device · Class II · 2019-03-27 · Fujifilm Medical Systems U - 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 M…
FDA Device · Class II · 2018-02-28 · Fujifilm Medical Systems U - ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mam…
FDA Device · Class II · 2018-02-28 · Fujifilm Medical Systems U - Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography imag…
FDA Device · Class II · 2018-02-28 · Fujifilm Medical Systems U - Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software…
FDA Device · Class II · 2018-02-28 · Fujifilm Medical Systems U - ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (…
FDA Device · Class II · 2018-01-24 · Fujifilm Medical Systems U - 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 ma…
FDA Device · Class II · 2018-01-24 · Fujifilm Medical Systems U - FUJIFILM FDR Visionary Suite with CH-200
FDA Device · Class II · 2017-12-20 · Fujifilm Medical Systems U - FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation…
FDA Device · Class II · 2017-10-04 · Fujifilm Medical Systems U - Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract
FDA Device · Class II · 2017-09-20 · Fujifilm Medical Systems U - Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and u…
FDA Device · Class II · 2017-09-20 · Fujifilm Medical Systems U - Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripher…
FDA Device · Class II · 2017-07-19 · Fujifilm Medical Systems U - Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management sys…
FDA Device · Class II · 2016-10-19 · Fujifilm Medical Systems U - FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, A…
FDA Device · Class II · 2016-09-07 · Fujifilm Medical Systems U - Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.…
FDA Device · Class II · 2016-06-29 · Fujifilm Medical Systems U - Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - Endoscope
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U - Smart CR Digital Computed Radiography System
FDA Device · Class II · 2016-05-11 · Fujifilm Medical Systems U - Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED…
FDA Device · Class II · 2015-12-23 · Fujifilm Medical Systems U - Fujinon/Fujifilm Processor EPX 2500 Operation Manual
FDA Device · Class II · 2015-09-30 · Fujifilm Medical Systems U - Fujifilm Processor EPX 2500 High Definition Endoscopy
FDA Device · Class II · 2015-09-30 · Fujifilm Medical Systems U - Fujifilm Medical Endoscope for the duodenum and upper G.I. tract
FDA Device · Class II · 2015-09-23 · Fujifilm Medical Systems U - Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Pict…
FDA Device · Class II · 2015-05-20 · Fujifilm Medical Systems U - FujiMedical Synapse Cardiovascular I ProSolv CardioVascular
FDA Device · Class II · 2015-05-20 · Fujifilm Medical Systems U - Aspire HD, Full Field Digital, System, x-Ray, Mammographic
FDA Device · Class II · 2015-05-13 · Fujifilm Medical Systems U