FUJIFILM Healthcare Americas Corporation
FDA Regulatory Profile
FUJIFILM Healthcare Americas Corporation appears in FDA public data with 23 recalls, 13 510(k) clearances, 16 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1299-2026, Class II) was initiated on January 9, 2026. Its most recent 510(k) clearance was granted on June 18, 2026.
Summary
- Total Recalls
- 23
- 510(k) Clearances
- 13
- Inspections
- 16
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1299-2026 | Class II | FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) | January 9, 2026 |
| Z-0044-2026 | Class II | FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-1613 | September 15, 2025 |
| Z-2219-2025 | Class II | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Dig | June 11, 2025 |
| Z-1407-2025 | Class II | Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, | February 11, 2025 |
| Z-1898-2024 | Class II | FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull | April 11, 2024 |
| Z-1884-2024 | Class II | Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24 | April 11, 2024 |
| Z-1268-2024 | Class II | Synapse PACS - Version 7.1.000 | January 10, 2024 |
| Z-1272-2024 | Class II | Synapse PACS - Version 7.2.200 | January 10, 2024 |
| Z-1270-2024 | Class II | Synapse PACS - Version 7.2.000 | January 10, 2024 |
| Z-1273-2024 | Class II | Synapse PACS - Version 7.3.000 | January 10, 2024 |
| Z-1269-2024 | Class II | Synapse PACS - Version 7.1.000US | January 10, 2024 |
| Z-1271-2024 | Class II | Synapse PACS - Version 7.2.100 | January 10, 2024 |
| Z-1171-2024 | Class II | Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user inte | January 3, 2024 |
| Z-1172-2024 | Class II | Synapse CV 6. with AR. A web-based application as the primary user interface for the processing o | January 3, 2024 |
| Z-3158-2024 | Class II | The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D- | November 23, 2023 |
| Z-1470-2023 | Class II | FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpo | February 27, 2023 |
| Z-1750-2022 | Class II | Surpria 64: Software Version V3.11, V3.22 | July 12, 2022 |
| Z-1748-2022 | Class II | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C | July 12, 2022 |
| Z-1749-2022 | Class II | Surpria: Software Version V3.11, V3.22 | July 12, 2022 |
| Z-0191-2022 | Class II | Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 | October 14, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261713 | Synapse PACS (7.6.0) | June 18, 2026 |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | September 26, 2025 |
| K243647 | Synapse PACS (7.5) | June 30, 2025 |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | June 13, 2024 |
| K233629 | APERTO Lucent MRI System | May 10, 2024 |
| K233687 | ECHELON Synergy V10.0 | May 3, 2024 |
| K233583 | FCT iSTREAM Phase 1 | April 26, 2024 |
| K240075 | FUJIFILM Endoscope Model EB-710XT | February 7, 2024 |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | December 13, 2023 |
| K231941 | ARIETTA x10 | November 20, 2023 |
| K231574 | Scenaria View 4.2 | October 12, 2023 |
| K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | September 15, 2023 |
| K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | September 1, 2023 |