FUJIFILM Healthcare Americas Corporation
15 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Feb 11, 2026
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FDA Devices Moderate Aug 6, 2025
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved …
FDA Devices Moderate Oct 2, 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 dete…
FDA Devices Moderate Jun 5, 2024
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and…
FDA Devices Moderate Mar 13, 2024
Synapse PACS - Version 7.2.100
FDA Devices Moderate Mar 13, 2024
Synapse PACS - Version 7.1.000
FDA Devices Moderate Mar 13, 2024
Synapse PACS - Version 7.2.000
FDA Devices Moderate Mar 13, 2024
Synapse PACS - Version 7.1.000US
FDA Devices Moderate Mar 13, 2024
Synapse PACS - Version 7.3.000
FDA Devices Moderate Feb 28, 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.
FDA Devices Moderate Feb 28, 2024
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FDA Devices Moderate Sep 21, 2022
Surpria 64: Software Version V3.11, V3.22
FDA Devices Moderate Sep 21, 2022
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FDA Devices Moderate Nov 10, 2021
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FDA Devices Moderate Nov 10, 2021