Data / Medical devices / United States / FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation: FDA-registered device maker in Twinsburg, OH, United States, 2 510(k) clearances
FUJIFILM Healthcare Americas Corporation is registered with the FDA (registration 1528028) in Twinsburg, OH, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 30, 2017. 42 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1528028
- Address
- 1959 Summit Commerce Park, Twinsburg, OH, United States, 44087
- Owner or operator
- FUJIFILM Healthcare Americas Corporation (10082284)
- Roles
- Specification developer
- First device listed
- May 31, 2022
- Registered through
- 2026
- Brand names listed
- C9150LA, S12BP4 Neurosurgery Probe, UST-9150
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2017 | K163505 | ARIETTA PRECISION | IYN | Substantially Equivalent | Hitachi , Ltd. | accessdata.fda.gov |
| April 12, 2013 | K122537 | PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 | IYN | Substantially Equivalent | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 14, 2021 | 88849 | Class II | Ongoing | Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 | 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 | accessdata.fda.gov |
| October 14, 2021 | 88840 | Class II | Ongoing | Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 | 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 ma | accessdata.fda.gov |
| July 29, 2021 | 88452 | Class II | Terminated | ECHELON MRI System | There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437. | accessdata.fda.gov |
| June 30, 2021 | 88367 | Class II | Ongoing | Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures | The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure. | accessdata.fda.gov |
| March 1, 2021 | 87493 | Class II | Terminated | Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoper | Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits. | accessdata.fda.gov |
| January 31, 2020 | 84838 | Class II | Terminated | UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardi | These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings. | accessdata.fda.gov |
| October 16, 2019 | 84133 | Class II | Terminated | Hitachi Scenaria Whole-body X-ray CT System | There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system. | accessdata.fda.gov |
| June 29, 2018 | 80671 | Class II | Terminated | Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in eithe | The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The problem could not be duplicated at the site, so to avoid further issues while a root cause investigation was pursued, Hitachi choose to add an opti | accessdata.fda.gov |
| June 18, 2018 | 80464 | Class II | Terminated | Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing | The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt. | accessdata.fda.gov |
| October 20, 2017 | 79160 | Class II | Terminated | Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures. | The ultrasound probe may not have adequate protection against electrical shock hazards. | accessdata.fda.gov |
| May 2, 2017 | 77051 | Class II | Terminated | Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation. | The strength of the arm mounting mechanism was insufficient and had to be redesigned. | accessdata.fda.gov |
| January 6, 2017 | 76056 | Class II | Terminated | Hitachi Oasis MRI System - C-Spine Coil | The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam. | accessdata.fda.gov |
| June 30, 2015 | 74714 | Class II | Terminated | Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087 | The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient. | accessdata.fda.gov |
| April 16, 2015 | 76373 | Class II | Terminated | Hitachi Oasis MRI System | Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. | accessdata.fda.gov |
| August 18, 2014 | 68758 | Class II | Terminated | Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of i | The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard. | accessdata.fda.gov |
| April 25, 2014 | 71431 | Class II | Terminated | Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-inv | The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched. | accessdata.fda.gov |
| January 31, 2013 | 65438 | Class II | Terminated | Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical i | Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the plac | accessdata.fda.gov |
| June 15, 2012 | 62870 | Class II | Terminated | Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and cli | Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal, coronal to sagittal, etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The softw | accessdata.fda.gov |
| May 4, 2012 | 62372 | Class II | Terminated | Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic mod | Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended and the task order changed, the second queue may not reconstruct the full range of slices. This may result in missing dia | accessdata.fda.gov |
| April 18, 2011 | 58703 | Not yet classified | Terminated | Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for | Software anomaly. The Doppler Trace Measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. The recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could | accessdata.fda.gov |
| April 19, 2010 | 55555 | Not yet classified | Terminated | Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO | Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk. | accessdata.fda.gov |
| September 1, 2009 | 54264 | Not yet classified | Terminated | Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, | The device has a software error that could potentially lead to a misdiagnosis. | accessdata.fda.gov |
| April 14, 2009 | 52430 | Not yet classified | Terminated | Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less. | Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect. | accessdata.fda.gov |
| November 5, 2008 | 50167 | Not yet classified | Terminated | Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collecte | Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal). | accessdata.fda.gov |
| May 12, 2008 | 52434 | Not yet classified | Terminated | EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. | The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly. | accessdata.fda.gov |
| February 25, 2008 | 47253 | Not yet classified | Terminated | EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information. | Miscalculation reading. A software error in the firm's EUB-5500/HI VISION diagnostic scanning system causes a miscalculation of the left ICA/CCA ratio when using the Carotid Calculation package for patient scans. | accessdata.fda.gov |
| February 11, 2008 | 47252 | Not yet classified | Terminated | Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation. | The firm's Altaire MR Scanner's Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient access leading to possible patient death or serious injury. | accessdata.fda.gov |
| July 30, 2007 | 44702 | Not yet classified | Terminated | Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) body. A portion of the c | Overheating; A portion (balun assembly) of the cable that connects the shoulder coil to the actual MRI unit may malfunction and result in overheating of the balun assembly. The overheating of the balun assembly could result in injury to the patient or operator if either came into contact with the assembly. | accessdata.fda.gov |
| August 16, 2006 | 36224 | Not yet classified | Terminated | MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J. | Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate. | accessdata.fda.gov |
| August 14, 2006 | 36525 | Not yet classified | Terminated | Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150. | Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating. | accessdata.fda.gov |
| April 28, 2006 | 35100 | Not yet classified | Terminated | AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems | Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis. | accessdata.fda.gov |
| April 25, 2006 | 35107 | Not yet classified | Terminated | Hitachi AIRIS II MRI System | Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections. | accessdata.fda.gov |
| March 17, 2006 | 35103 | Not yet classified | Terminated | MRP-7000, AIRIS Magnetic Resonance Imaging Systems | Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis. | accessdata.fda.gov |
| February 21, 2006 | 35087 | Not yet classified | Terminated | Magnetic Resonance Imaging Device | The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures. | accessdata.fda.gov |
| February 21, 2006 | 35086 | Not yet classified | Terminated | Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT) | The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized. | accessdata.fda.gov |
| February 21, 2006 | 35081 | Not yet classified | Terminated | Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT) | The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them. | accessdata.fda.gov |
| January 27, 2006 | 34856 | Not yet classified | Terminated | Hitachi Altaire Magnetic Resonance Imaging System | Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost. | accessdata.fda.gov |
| December 1, 2005 | 34060 | Not yet classified | Terminated | The AIRIS MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces tra | The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches. | accessdata.fda.gov |
| June 30, 2005 | 32211 | Not yet classified | Terminated | Hitachi Altaire Magnetic Resonance Imaging Device. | Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder. | accessdata.fda.gov |
| April 11, 2005 | 31768 | Not yet classified | Terminated | Altaire, Magnetic Resonance Imaging Device. | The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard. | accessdata.fda.gov |
| November 18, 2004 | 31772 | Not yet classified | Terminated | Altaire, Magnetic Resonance Imaging Device. | The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor. | accessdata.fda.gov |
| May 7, 2004 | 29160 | Not yet classified | Terminated | Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W. | Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated May 30, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.