Fujifilm Healthcare Americas Corporation
Lexington, MA
This page shows every FDA and USDA recall linked to Fujifilm Healthcare Americas Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
19
Total Recalls
2022
First Recall
2026
Most Recent
FDR Visionary Suite;
Model Number: CH-200;
Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Feb 5, 2026
· Device
Open, Classified
FDR Visionary Suite, CH-200
Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Oct 7, 2025
· Device
Open, Classified
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breas...
Jul 30, 2025
· Device
Open, Classified
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.
Mar 20, 2025
· Device
Open, Classified
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-I...
Sep 25, 2024
· Device
Open, Classified
FDR Visionary Suite - Intended to generate digital or conventional radiographic
images of the skull, spinal co...
May 24, 2024
· Device
Open, Classified
Noblus AC Adapter used with the Noblus Ultrasound Imaging System
Model : AHM250PS24
May 22, 2024
· Device
Open, Classified
Synapse PACS - Version 7.2.000
Mar 7, 2024
· Device
Open, Classified
Synapse PACS - Version 7.2.200
Mar 7, 2024
· Device
Open, Classified
Synapse PACS - Version 7.1.000
Mar 7, 2024
· Device
Open, Classified
Synapse PACS - Version 7.2.100
Mar 7, 2024
· Device
Open, Classified
Synapse PACS - Version 7.3.000
Mar 7, 2024
· Device
Open, Classified
Synapse PACS - Version 7.1.000US
Mar 7, 2024
· Device
Open, Classified
Synapse CV 6. with AR.
A web-based application as the primary user interface for the processing of medical i...
Feb 21, 2024
· Device
Open, Classified
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0.
A web-based application as the primary user interface for t...
Feb 21, 2024
· Device
Open, Classified
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiogr...
Apr 27, 2023
· Device
Open, Classified
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Jul 12, 2022
· Device
Open, Classified
Surpria: Software Version V3.11, V3.22
Jul 12, 2022
· Device
Open, Classified
Surpria 64: Software Version V3.11, V3.22
Jul 12, 2022
· Device
Open, Classified