| FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3 recall (Z-1299-2026) | FUJIFILM Healthcare Americas Corporation | 2026-02-05 |
| FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) recall (Z-0044-2026) | FUJIFILM Healthcare Americas Corporation | 2025-10-07 |
| ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cri recall (Z-2219-2025) | FUJIFILM Healthcare Americas Corporation | 2025-07-30 |
| Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100 recall (Z-1407-2025) | FUJIFILM Healthcare Americas Corporation | 2025-03-20 |
| The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintilla recall (Z-3158-2024) | FUJIFILM Healthcare Americas Corporation | 2024-09-25 |
| FDR Visionary Suite - Intended to generate digital or conventional radiographic images of recall (Z-1898-2024) | FUJIFILM Healthcare Americas Corporation | 2024-05-24 |
| Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24 recall (Z-1884-2024) | FUJIFILM Healthcare Americas Corporation | 2024-05-22 |
| Synapse PACS - Version 7.1.000 recall (Z-1268-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.1.000US recall (Z-1269-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.2.000 recall (Z-1270-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.2.100 recall (Z-1271-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.2.200 recall (Z-1272-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse PACS - Version 7.3.000 recall (Z-1273-2024) | FUJIFILM Healthcare Americas Corporation | 2024-03-07 |
| Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary u recall (Z-1171-2024) | FUJIFILM Healthcare Americas Corporation | 2024-02-21 |
| Synapse CV 6. with AR. A web-based application as the primary user interface for the proce recall (Z-1172-2024) | FUJIFILM Healthcare Americas Corporation | 2024-02-21 |
| FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in gen recall (Z-1470-2023) | FUJIFILM Healthcare Americas Corporation | 2023-04-27 |