| 2026-07-22 |
Class II
|
Ongoing |
Z-3030-2026 |
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system |
— |
Software issue may cause the ruler measurement to be inaccurate. |
| 2026-01-09 |
Class II
|
Ongoing |
Z-1299-2026 |
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) |
— |
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 … |
| 2025-09-15 |
Class II
|
Ongoing |
Z-0044-2026 |
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33 |
— |
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 effect… |
| 2025-06-11 |
Class II
|
Ongoing |
Z-2219-2025 |
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt… |
— |
Devices had an unapproved slabbing software function enabled for use. |
| 2025-02-11 |
Class II
|
Ongoing |
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. |
— |
The incorrect computed patient age is showing in VX for patients less than 3 months old. |
| 2024-04-11 |
Class II
|
Ongoing |
Z-1898-2024 |
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, che… |
— |
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury |
| 2024-04-11 |
Class II
|
Ongoing |
Z-1884-2024 |
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24 |
— |
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 ins… |
| 2024-01-10 |
Class II
|
Ongoing |
Z-1273-2024 |
Synapse PACS - Version 7.3.000 |
— |
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… |
| 2024-01-10 |
Class II
|
Ongoing |
Z-1272-2024 |
Synapse PACS - Version 7.2.200 |
— |
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… |
| 2024-01-10 |
Class II
|
Ongoing |
Z-1271-2024 |
Synapse PACS - Version 7.2.100 |
— |
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… |
| 2024-01-10 |
Class II
|
Ongoing |
Z-1270-2024 |
Synapse PACS - Version 7.2.000 |
— |
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… |
| 2024-01-10 |
Class II
|
Ongoing |
Z-1269-2024 |
Synapse PACS - Version 7.1.000US |
— |
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… |
| 2024-01-10 |
Class II
|
Ongoing |
Z-1268-2024 |
Synapse PACS - Version 7.1.000 |
— |
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… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-1172-2024 |
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images. |
— |
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 fo… |
| 2024-01-03 |
Class II
|
Ongoing |
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 proces… |
— |
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 fo… |
| 2023-11-23 |
Class II
|
Ongoing |
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)… |
— |
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 imagin… |
| 2023-02-27 |
Class II
|
Ongoing |
Z-1470-2023 |
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for g… |
— |
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 … |
| 2022-07-12 |
Class II
|
Ongoing |
Z-1750-2022 |
Surpria 64: Software Version V3.11, V3.22 |
— |
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.res… |
| 2022-07-12 |
Class II
|
Ongoing |
Z-1749-2022 |
Surpria: Software Version V3.11, V3.22 |
— |
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.res… |
| 2022-07-12 |
Class II
|
Ongoing |
Z-1748-2022 |
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C |
— |
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.res… |
| 2021-10-14 |
Class II
|
Ongoing |
Z-0192-2022 |
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 |
— |
When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regur… |
| 2021-10-14 |
Class II
|
Ongoing |
Z-0191-2022 |
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 |
— |
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the meas… |
| 2021-10-14 |
Class II
|
Ongoing |
Z-0190-2022 |
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 |
— |
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the meas… |
| 2021-10-14 |
Class II
|
Ongoing |
Z-0189-2022 |
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 |
— |
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the meas… |