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Fujifilm Medical Systems U.s.a., Inc. Recalls

23 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Fujifilm Medical Systems U.s.a., Inc..

23Total Recalls
1Critical
6,466Units Affected
Feb 18, 2021Most Recent
All Recalls

Every Fujifilm Medical Systems U.s.a., Inc. Recall

Sorted by most recent. Click any recall for full details.

23 recalls
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Medical Devices·496 affected·Feb 18, 2021
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
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 ex...
Medical Devices·1 affected·Sep 11, 2020
CriticalFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm FDR Go Plus mobile X-ray system
Medical Devices·174 affected·Jul 19, 2019
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a sof...
Medical Devices·71 affected·Aug 4, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digit...
Medical Devices·71 affected·Aug 4, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s ...
Medical Devices·71 affected·Aug 4, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ...
Medical Devices·15 affected·Jul 14, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is in...
Medical Devices·3 affected·Jun 15, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information manageme...
Medical Devices·251 affected·Sep 15, 2016
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography Syst...
Medical Devices·2 affected·Jun 9, 2016
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Medical Devices·2,062 affected·Apr 1, 2016
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Medical Devices·98 affected·Dec 23, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Medical Devices·94 affected·Dec 23, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
Medical Devices·882 affected·Dec 23, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Medical Devices·1,473 affected·Dec 23, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, an...
Medical Devices·79 affected·Aug 31, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and ...
Medical Devices·0 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Ope...
Medical Devices·256 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Medical Devices·60 affected·Jun 30, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the...
Medical Devices·260 affected·Mar 9, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended U...
Diagnostic Devices·16 affected·Feb 4, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synaps...
Medical Devices·30 affected·Feb 4, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis...
Medical Devices·1 affected·Feb 3, 2015