Lexington, MA, United States
FUJIFILM Healthcare Americas Corporation recalls
14 recalls recorded since 2018, most recently on 22 July 2026. 14 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)14
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 July 2026
- Reason
- Software issue may cause the ruler measurement to be inaccurate.
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3030-2026
- FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Ongoing Class II Medical devices
- Recall started
- 9 January 2026
- Reason
- It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
- Distribution
- US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1299-2026
- FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Ongoing Class II Medical devices
- Recall started
- 15 September 2025
- Reason
- It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
- Distribution
- Domestic: AK, CA, FL, IL, MA, NH, OH, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0044-2026
- FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Ongoing Class II Medical devices
- Recall started
- 11 June 2025
- Reason
- Devices had an unapproved slabbing software function enabled for use.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2219-2025
- ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Ongoing Class II Medical devices
- Recall started
- 11 February 2025
- Reason
- The incorrect computed patient age is showing in VX for patients less than 3 months old.
- Distribution
- Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY. International: Australia, Belgium, Brazil, France, Germany, Portugal, UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1407-2025
- Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Ongoing Class II Medical devices
- Recall started
- 11 April 2024
- Reason
- Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
- Distribution
- US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1898-2024
- FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examin
Ongoing Class II Medical devices
- Recall started
- 11 April 2024
- Reason
- AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1884-2024
- Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Ongoing Class II Medical devices
- Recall started
- 10 January 2024
- Reason
- Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
- Distribution
- Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1271-2024, Z-1268-2024, Z-1270-2024, Z-1269-2024, Z-1273-2024, Z-1272-2024
- Synapse PACS - Version 7.2.100
- Synapse PACS - Version 7.1.000
- Synapse PACS - Version 7.2.000
- Synapse PACS - Version 7.1.000US
- Synapse PACS - Version 7.3.000
- Synapse PACS - Version 7.2.200
Ongoing Class II Medical devices
- Recall started
- 3 January 2024
- Reason
- The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
- Distribution
- US domestic distribution nationwide. International distribution to Israel.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1171-2024, Z-1172-2024
- Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
- Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Ongoing Class II Medical devices
- Recall started
- 23 November 2023
- Reason
- When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.
- Distribution
- US Nationwide and Worldwide
- Initiated
- FDA Mandated
- Recall number
- Z-3158-2024
- The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Ongoing Class II Medical devices
- Recall started
- 27 February 2023
- Reason
- Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1470-2023
- FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Ongoing Class II Medical devices
- Recall started
- 12 July 2022
- Reason
- Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1750-2022, Z-1748-2022, Z-1749-2022
- Surpria 64: Software Version V3.11, V3.22
- SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
- Surpria: Software Version V3.11, V3.22
Ongoing Class II Medical devices
- Recall started
- 14 October 2021
- Reason
- Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0190-2022, Z-0191-2022, Z-0189-2022
- Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
- Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
- Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Ongoing Class II Medical devices
- Recall started
- 14 October 2021
- Reason
- When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0192-2022
- Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
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.