Lexington, MA, United States
Fujifilm Medical Systems U.S.A., Inc. recalls
12 recalls recorded since 2018, most recently on 30 April 2021. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)3
Terminated or completed9
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 30 April 2021
- Terminated
- 29 July 2024
- 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 patient merge activity is executed in a specific sequence
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1775-2021
- Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Ongoing Class II Medical devices
- Recall started
- 2 March 2021
- Reason
- The wrong patient information may be displayed in the viewer or PowerJacket.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and the countries of United Arab Emirates, Ang
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1348-2021
- Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PA
Terminated Class II Medical devices
- Recall started
- 18 February 2021
- Terminated
- 24 February 2022
- Reason
- Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
- Distribution
- CA, LA, MN, NC, UT, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1412-2021
- ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Terminated Class III Medical devices
- Recall started
- 22 December 2020
- Terminated
- 20 July 2021
- 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.
- Distribution
- US Nationwide distribution including in the states of MO, OR, MD, PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0932-2021
- 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 density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C)
Terminated Class II Medical devices
- Recall started
- 11 December 2020
- Terminated
- 17 November 2021
- 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.
- Distribution
- US Nationwide distribution in the state of MD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0918-2021
- 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 PC which meets or exceeds minimum specifications and is networked with a FUJIFILM
Terminated Class II Medical devices
- Recall started
- 11 September 2020
- Terminated
- 17 November 2021
- 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.
- Distribution
- US Nationwide distribution including in the state of Minnesota.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0282-2021
- 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 exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Ongoing Class II Medical devices
- Recall started
- 11 September 2020
- 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 Modality.
- Distribution
- Software was distributed to medical facilities nationwide throughout the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0878-2021
- Synapse PACS Software Versions 5.1 and higher
Ongoing Class II Medical devices
- Recall started
- 22 May 2020
- 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 well, and result in misdiagnosis
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2471-2020
- Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
Terminated Class II Medical devices
- Recall started
- 19 July 2019
- Terminated
- 28 August 2020
- Reason
- The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2441-2019
- Fujifilm FDR Go Plus mobile X-ray system
Terminated Class II Medical devices
- Recall started
- 15 January 2019
- Terminated
- 8 October 2020
- 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.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1040-2019
- 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 patients in the hospital who cannot move and/or of outpatients in emergency. E
Terminated Class II Medical devices
- Recall started
- 4 August 2017
- Terminated
- 1 April 2019
- 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 every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
- Distribution
- Worldwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0662-2018, Z-0661-2018, Z-0660-2018, Z-0659-2018
- Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system
- ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be
- 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 MS-2000), generate full-field digital mammography images that can, as other fu
- Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for scre
Terminated Class II Medical devices
- Recall started
- 14 July 2017
- Terminated
- 20 July 2018
- Reason
- There was a case that the swivel arm went down unintentionally when it was moved up/down.
- Distribution
- US Distribution and Internationally to Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0386-2018, Z-0385-2018
- ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as oth
- 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 machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-250
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.