← Every firm
FUJIFILM Healthcare Americas Corporation FDA Recalls
24 recalls on file across devices, 0 of them Class I and 24 still open. Matched by name to FUJIY.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| FUJIFILM Synapse PACS software v7.4.310; radiological image processing systemClass IIJul 22, 2026Software issue may cause the ruler measurement to be inaccur |
| FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)Class IIJan 9, 2026It was found that the contacts of the electromagnetic contac |
| FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33Class IISep 15, 2025It was found that the shaft for mounting the X-ray tube unit |
| ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast TomosyntClass IIJun 11, 2025Devices had an unapproved slabbing software function enabled |
| 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.Class IIFeb 11, 2025The incorrect computed patient age is showing in VX for pati |
| Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24Class IIApr 11, 2024AC adapters of Noblus can heat up, and cause smoke in the wo |
| FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, cheClass IIApr 11, 2024Bolts on the CH-200 tube may rupture due to fatigue failure, |
| Synapse PACS - Version 7.1.000USClass IIJan 10, 2024Measurements on a Secondary Capture 2D image, that does not |
| Synapse PACS - Version 7.2.100Class IIJan 10, 2024Measurements on a Secondary Capture 2D image, that does not |
| Synapse PACS - Version 7.1.000Class IIJan 10, 2024Measurements on a Secondary Capture 2D image, that does not |
| Synapse PACS - Version 7.2.000Class IIJan 10, 2024Measurements on a Secondary Capture 2D image, that does not |
| Synapse PACS - Version 7.2.200Class IIJan 10, 2024Measurements on a Secondary Capture 2D image, that does not |
| Synapse PACS - Version 7.3.000Class IIJan 10, 2024Measurements on a Secondary Capture 2D image, that does not |
| Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.Class IIJan 3, 2024The LV Mass (2D Bullet) equation may be calculated incorrect |
| Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the procesClass IIJan 3, 2024The LV Mass (2D Bullet) equation may be calculated incorrect |
| The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE)Class IINov 23, 2023When the key switch is turned on, the exposure conditions ar |
| FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for gClass IIFeb 27, 2023Arm which holds the tube head in place is susceptible to bre |
| Surpria: Software Version V3.11, V3.22Class IIJul 12, 2022Error 00003050 or 00003052 may occur during scanning, the c |
| Surpria 64: Software Version V3.11, V3.22Class IIJul 12, 2022Error 00003050 or 00003052 may occur during scanning, the c |
| SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0CClass IIJul 12, 2022Error 00003050 or 00003052 may occur during scanning, the c |
| Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3Class IIOct 14, 2021Diagnostic ultrasound system with the specified software ver |
| Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0Class IIOct 14, 2021When the ultrasound system is used in combination with a Fuj |
| Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3Class IIOct 14, 2021Diagnostic ultrasound system with the specified software ver |
| Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3Class IIOct 14, 2021Diagnostic ultrasound system with the specified software ver |