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Fujifilm Medical Systems U.S.A Recalls
37 recalls on record · May 13, 2015 to June 9, 2021 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 23, 2015Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-41
Hazard: A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
September 30, 2015Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to obs
Hazard: The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.
September 30, 2015Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Hazard: The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.
September 23, 2015Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450
Hazard: The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.
May 20, 2015Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 S
Hazard: Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.
May 20, 2015Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software
Hazard: Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
May 13, 2015Medical DevicesFDA
Fujifilm Medical Systems U.S.A., Inc. recalls Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screen
Hazard: User Manual lacks a description for handling some errors even though the system can be recovered from such errors