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.
Recall summary
| Recall notices | 37 |
|---|---|
| Published | 2015-05-13 to 2021-06-09 |
| By agency | FDA Device (37) |
| By classification | Class II (36), Class III (1) |
| By status | terminated (34), ongoing (3) |
| Distribution named in notices | AL, CA, CO, FL, HI, IA, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NY, OH, OR, PA, PR, TN, TX, US, UT, VA, WA, WI |
Recalls
- 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
Reason: Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a… - ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
FDA Device · Class II · 2021-04-21 · Fujifilm Medical Systems U
Reason: Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result - 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
Reason: The wrong patient information may be displayed in the viewer or PowerJacket. - 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
Reason: The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user. - 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
Reason: FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing. - Synapse PACS Software Versions 5.1 and higher
FDA Device · Class II · 2021-01-27 · Fujifilm Medical Systems U
Reason: There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modali… - 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
Reason: FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected. - 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
Reason: Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as… - Fujifilm FDR Go Plus mobile X-ray system
FDA Device · Class II · 2019-09-11 · Fujifilm Medical Systems U
Reason: The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD) - 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
Reason: FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released. - 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
Reason: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to… - 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
Reason: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to… - 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
Reason: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to… - 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
Reason: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to… - 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
Reason: There was a case that the swivel arm went down unintentionally when it was moved up/down. - 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
Reason: There was a case that the swivel arm went down unintentionally when it was moved up/down. - FUJIFILM FDR Visionary Suite with CH-200
FDA Device · Class II · 2017-12-20 · Fujifilm Medical Systems U
Reason: A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part… - 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
Reason: An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal,… - 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
Reason: Fujifilm is reporting a corrective action due to an FDA inspection. - 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
Reason: Fujifilm is conducting a corrective action due to an FDA inspection. - 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
Reason: Fujifilm is recalling multiple endoscopes after a retrospective review. - 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
Reason: Image data for a patients image may not be correct - 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
Reason: If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly. - 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
Reason: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead - Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U
Reason: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures. - Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U
Reason: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures. - Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U
Reason: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures. - Endoscope
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U
Reason: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures. - Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
FDA Device · Class II · 2016-06-08 · Fujifilm Medical Systems U
Reason: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures. - Smart CR Digital Computed Radiography System
FDA Device · Class II · 2016-05-11 · Fujifilm Medical Systems U
Reason: Reports of failure of the device's power supply. - 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
Reason: A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing. - Fujinon/Fujifilm Processor EPX 2500 Operation Manual
FDA Device · Class II · 2015-09-30 · Fujifilm Medical Systems U
Reason: 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 end… - Fujifilm Processor EPX 2500 High Definition Endoscopy
FDA Device · Class II · 2015-09-30 · Fujifilm Medical Systems U
Reason: 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 end… - Fujifilm Medical Endoscope for the duodenum and upper G.I. tract
FDA Device · Class II · 2015-09-23 · Fujifilm Medical Systems U
Reason: 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. - 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
Reason: 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. - FujiMedical Synapse Cardiovascular I ProSolv CardioVascular
FDA Device · Class II · 2015-05-20 · Fujifilm Medical Systems U
Reason: Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. - Aspire HD, Full Field Digital, System, x-Ray, Mammographic
FDA Device · Class II · 2015-05-13 · Fujifilm Medical Systems U
Reason: User Manual lacks a description for handling some errors even though the system can be recovered from such errors