| Z-0044-2026 |
FDR Visionary Suite, CH-200
Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
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.
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2025-09-15 |
Open, Classified
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| Z-0189-2022 |
Arietta 750 Ultrasound
Software Version: V1.0.0 through V2.1.3
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.
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2021-10-14 |
Open, Classified
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| Z-0190-2022 |
Arietta 850 Ultrasound-
Software Version: V1.0.0 through V4.1.3
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.
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2021-10-14 |
Open, Classified
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View Details
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| Z-0191-2022 |
Lisendo 880 Ultrasound
Software Version: V1.0 through V4.1.3
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.
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2021-10-14 |
Open, Classified
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View Details
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| Z-0192-2022 |
Arietta 65 Ultrasound
Software Versions: V1.0 through V4.0.0
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
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2021-10-14 |
Open, Classified
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| Z-1171-2024 |
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.
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.
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2024-01-03 |
Open, Classified
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| Z-1172-2024 |
Synapse CV 6. with AR.
A web-based application as the primary user interface for the processing of medical images.
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.
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2024-01-03 |
Open, Classified
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View Details
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| Z-1268-2024 |
Synapse PACS - Version 7.1.000
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.
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2024-01-10 |
Open, Classified
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View Details
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| Z-1269-2024 |
Synapse PACS - Version 7.1.000US
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.
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2024-01-10 |
Open, Classified
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View Details
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| Z-1270-2024 |
Synapse PACS - Version 7.2.000
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.
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2024-01-10 |
Open, Classified
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View Details
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| Z-1271-2024 |
Synapse PACS - Version 7.2.100
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.
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2024-01-10 |
Open, Classified
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View Details
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| Z-1272-2024 |
Synapse PACS - Version 7.2.200
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.
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2024-01-10 |
Open, Classified
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View Details
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| Z-1273-2024 |
Synapse PACS - Version 7.3.000
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.
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2024-01-10 |
Open, Classified
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View Details
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| Z-1299-2026 |
FDR Visionary Suite;
Model Number: CH-200;
Version: (1) 566-16130-23, (2) 566-16130-31, (3)
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.
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2026-01-09 |
Open, Classified
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View Details
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| 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.
Reason: The incorrect computed patient age is showing in VX for patients less than 3 months old.
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2025-02-11 |
Open, Classified
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| 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
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.
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2023-02-27 |
Open, Classified
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| Z-1748-2022 |
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
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
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2022-07-12 |
Open, Classified
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View Details
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| Z-1749-2022 |
Surpria: Software Version V3.11, V3.22
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
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2022-07-12 |
Open, Classified
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View Details
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| Z-1750-2022 |
Surpria 64: Software Version V3.11, V3.22
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
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2022-07-12 |
Open, Classified
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View Details
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| Z-1884-2024 |
Noblus AC Adapter used with the Noblus Ultrasound Imaging System
Model : AHM250PS24
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).
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2024-04-11 |
Open, Classified
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View Details
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| 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 examinations.
Model/Catalog Number:
566-16130-23
566-16130-33
Reason: Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
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2024-04-11 |
Open, Classified
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View Details
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| Z-2219-2025 |
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Reason: Devices had an unapproved slabbing software function enabled for use.
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2025-06-11 |
Open, Classified
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View Details
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| 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.
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.
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2023-11-23 |
Open, Classified
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View Details
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