Manufacturer
37 recalls in our database name Fujifilm Medical Systems U.S.A., Inc. as the manufacturing or recalling firm.
Of the 37 recalls from Fujifilm Medical Systems U.S.A., Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Fujifilm Medical Systems is correcting the ED-530XT endoscope manual to address reports of multi-drug resistant bacteria found on endoscopes used in ERCP procedures.
Fujifilm Medical Systems is correcting the ED-250XL5 endoscope operations manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Fujifilm Medical Systems is correcting the operation manual for the ED-450XL5 endoscope to address publicized reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Fujifilm Medical Systems is recalling 882 ED-250XT5 endoscope operations manuals following reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Fujifilm Medical Systems is recalling 2,062 Smart CR Digital Computed Radiography Systems due to reports of power supply failure.
Fujifilm Medical Systems is recalling specific duodenoscope models as a precautionary measure because the devices have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
Fujifilm is recalling 60 EPX 2500 Operation Manuals and sales brochures that incorrectly identify the ED-530XT endoscope's image capabilities.
Fujifilm is recalling EPX 2500 Processor manuals and brochures that incorrectly identify the ED-530XT endoscope's image quality.
Fujifilm Medical Systems U.S.A., Inc. is recalling 256 endoscope operation manuals because the suction button may become stuck after using x-ray contrast agents.
Fujifilm Medical Systems is recalling Synapse Cardiovascular software because measurement values in the EMR may not match clinical reports.
Fujifilm Medical Systems is recalling Synapse Cardiovascular software versions v4.0.8 and v4.0.8 SR1 because patient demographics in exported reports may not match the clinical reports.
Fujifilm is recalling one Aspire HD mammography system in Hawaii because the user manual lacks descriptions for handling certain recoverable errors.