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FUJIFILM Healthcare Americas Corporation

United States·US-MF-000009244

Last updated September 17, 2026

Information

Country: United States
Address: 81, Hartwell Avenue, Lexington, United States
Website: fujifilm.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Liza Dejesa-Jamanila
EUDAMED SRN: US-MF-000009244
FDA FEI Number: 3004972322
DUNS Number: —

Catalogue (38)

Device	Model / Reference	Registries	Class	Status
Ust-9150	UST-9150	FDA UDI	Class II	Active
VidiStar PACS & DICOM Viewer Software	4.X.X	FDA UDI	Class II	Active
Trillium Oval	TRILLIUM OVAL	FDA UDI	Class II	Active
C9150la	C9150LA	FDA UDI	Class II	Active
Synapse Pathology	Synapse Pathology Software License	FDA UDI	Class II	Active
Hitachi Healthcare Americas	UST-52114P-B	FDA UDI	Class II	Unknown
Das-Rs1	DAS-RS1	FDA UDI	Class II	Active
Synapse Radiology PACS	Synapse Radiology PACS Software License	FDA UDI	Class II	Active
Synapse Enterprise Viewer	Synapse Enterprise Viewer	FDA UDI	Class II	Active
Transducer S12BP4	S12BP4	FDA UDI	Class II	Active
Synapse MPR Fusion	Synapse MPR Fusion Software License	FDA UDI	Class II	Active
Hitachi Healthcare Americas	C9150LA	FDA UDI	Class II	Unknown
Ust 5550-R	UST 5550-R	FDA UDI	Class II	Active
Hitachi Healthcare Americas	UST-9150	FDA UDI	Class II	Unknown
Hitachi Healthcare Americas	UST-5550-R	FDA UDI	Class II	Unknown
D&K Technologies	DK-ARM-KIT	FDA UDI	Class I	Active
D&K Technologies	DK-STAND-KIT	FDA UDI	Class I	Active
Ust-52114p-B	UST-52114P-B	FDA UDI	Class II	Active
Synapse Mobility	Synapse Mobility Base Package	FDA UDI	Class II	Active
ECHELON Synergy MRI system	K223426	FDA 510(k)	Class II	Active
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	K230752	FDA 510(k)	Class II	Active
ECHELON Synergy V10.0	K233687	FDA 510(k)	Class II	Active
FCT iSTREAM Phase 1	K233583	FDA 510(k)	Class II	Active
ECHELON Oval V6.2 MRI System	K221619	FDA 510(k)	Class II	Active
ARIETTA x10	K231941	FDA 510(k)	Class II	Active
Synapse PACS (7.5)	K243647	FDA 510(k)	Class II	Active
Arietta 50	K220295	FDA 510(k)	Class II	Active
Scenaria View 4.2	K231574	FDA 510(k)	Class II	Active
FUJIFILM Stiffening Wire Device (SW-2000)	K251204	FDA 510(k)	Class II	Active
Double Balloon Endoscope EN-840T, Over-tube TS-1214C	K233321	FDA 510(k)	Class II	Active
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	K231666	FDA 510(k)	Class II	Active
OASIS MRI System	K240571	FDA 510(k)	Class II	Active
ECHELON Synergy MRI System	K241429	FDA 510(k)	Class II	Active
FUJIFILM Endoscope Model EB-710XT	K240075	FDA 510(k)	Class II	Active
APERTO Lucent MRI System	K233629	FDA 510(k)	Class II	Active
SCENARIA View	K213829	FDA 510(k)	Class II	Active
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	K232314	FDA 510(k)	Class II	Active
Synapse CV	Synapse CV	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

FUJIFILM Healthcare Europe GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (23)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 9, 2026	Z-1299-2026	—	open, classified	It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
Sep 15, 2025	Z-0044-2026	—	open, classified	It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Jun 11, 2025	Z-2219-2025	—	open, classified	Devices had an unapproved slabbing software function enabled for use.
Feb 11, 2025	Z-1407-2025	—	open, classified	The incorrect computed patient age is showing in VX for patients less than 3 months old.
Apr 11, 2024	Z-1898-2024	—	open, classified	Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Apr 11, 2024	Z-1884-2024	—	open, classified	AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Jan 10, 2024	Z-1269-2024	—	open, classified	Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Jan 10, 2024	Z-1270-2024	—	open, classified	Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Jan 10, 2024	Z-1271-2024	—	open, classified	Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Jan 10, 2024	Z-1268-2024	—	open, classified	Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Jan 10, 2024	Z-1273-2024	—	open, classified	Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Jan 10, 2024	Z-1272-2024	—	open, classified	Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Jan 3, 2024	Z-1171-2024	—	open, classified	The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Jan 3, 2024	Z-1172-2024	—	open, classified	The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Nov 23, 2023	Z-3158-2024	—	open, classified	When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.
Feb 27, 2023	Z-1470-2023	—	open, classified	Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.
Jul 12, 2022	Z-1748-2022	—	open, classified	Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
Jul 12, 2022	Z-1750-2022	—	open, classified	Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
Jul 12, 2022	Z-1749-2022	—	open, classified	Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
Oct 14, 2021	Z-0192-2022	—	open, classified	When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual
Oct 14, 2021	Z-0191-2022	—	open, classified	Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
Oct 14, 2021	Z-0189-2022	—	open, classified	Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
Oct 14, 2021	Z-0190-2022	—	open, classified	Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.