Hitachi Medical Systems America, Inc.
United StatesFDA applicant, unverified
- Devices
- 100
- FDA recalls
- 45
At a glance
Market reach
- United States
- FDA recalls
What Hitachi Medical Systems America, Inc. makes
The company manufactures mobile and fixed MRI systems, including the Sirius Starmobile tiara and ECHELON Oval V 5.1, as well as dedicated MRI coils such as the ECHELON Cardiac Coil and High Resolution Foot Coil. It also produces computed tomography (CT) systems like the ECLOS CT X-ray, angiography tools including the 2D TOF Angiography Measuring Function, and ECG monitors such as the DS-3130/3140. Additional offerings include MRI-compatible ECG gating hardware and diagnostic magnetic resonance devices like the MRP-5000.
These devices are classified under Class II by the FDA and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Search and filter all 100 devicesShowing 1-50 of 100
FDA recalls
FDA recall records list 45 recalls initiated by Hitachi Medical Systems America, Inc., the earliest on 2004-05-07 and the most recent on 2021-03-01. By recorded status: 45 terminated. The reasons filed fall into these groups: software or firmware, packaging, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 3
- 2018 2
- 2019 1
- 2020 1
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 1 Mar 2021 Z-1282-2021 Class II Terminated 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.
2020
- 31 Jan 2020 Z-1341-2020 Class II Terminated These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
2019
- 16 Oct 2019 Z-0271-2020 Class II Terminated 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.
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- 16 Oct 2019 Z-0271-2020 Class II Terminated 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.
2018
- 29 Jun 2018 Z-2839-2018 Class II Terminated 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 optional touch sensor to the gantry to add a redundant level of protection. It is conceivable that a patient s extremity may be caught between the tabletop and the gantry surface during uncontrolled motion or that the table contact of the gantry might cause internal damage to the unit.
- 18 Jun 2018 Z-2479-2018 Class II Terminated 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.
2017
- 20 Oct 2017 Z-0816-2018 Class II Terminated The ultrasound probe may not have adequate protection against electrical shock hazards.
- 2 May 2017 Z-2090-2017 Class II Terminated The strength of the arm mounting mechanism was insufficient and had to be redesigned.
- 6 Jan 2017 Z-1096-2017 Class II Terminated The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
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2015
- 30 Jun 2015 Z-2392-2016 Class II Terminated 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.
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- 16 Apr 2015 Z-1540-2017 Class II Terminated Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
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- 30 Jun 2015 Z-2392-2016 Class II Terminated 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.
Show the 25 most recent of 45 recalls
2015
- 16 Apr 2015 Z-1541-2017 Class II Terminated Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
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- 16 Apr 2015 Z-1542-2017 Class II Terminated Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
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- 16 Apr 2015 Z-1541-2017 Class II Terminated Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
2014
- 18 Aug 2014 Z-2564-2014 Class II Terminated The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
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- 25 Apr 2014 Z-2366-2015 Class II Terminated The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
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- 18 Aug 2014 Z-2564-2014 Class II Terminated The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
2013
- 31 Jan 2013 Z-1559-2013 Class II Terminated 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 place of the original image, which is lost.
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- 31 Jan 2013 Z-1559-2013 Class II Terminated 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 place of the original image, which is lost.
2012
- 15 Jun 2012 Z-2254-2012 Class II Terminated 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 software error can occur randomly when execu
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- 4 May 2012 Z-2037-2012 Class II Terminated 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 diagnostic data.
- 15 Jun 2012 Z-2254-2012 Class II Terminated 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 software error can occur randomly when execu
2011
- 18 Apr 2011 Z-2467-2011 Unclassified (pre-2012) Terminated 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 be lower than at the true velocity lead
2010
- 19 Apr 2010 Z-1616-2010 Unclassified (pre-2012) Terminated 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.
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- 19 Apr 2010 Z-1616-2010 Unclassified (pre-2012) Terminated 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.
2009
- 1 Sep 2009 Z-1534-2010 Unclassified (pre-2012) Terminated The device has a software error that could potentially lead to a misdiagnosis.
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- 14 Apr 2009 Z-1651-2009 Unclassified (pre-2012) Terminated 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.
- 14 Apr 2009 Z-1652-2009 Unclassified (pre-2012) Terminated 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.
- 1 Sep 2009 Z-1534-2010 Unclassified (pre-2012) Terminated The device has a software error that could potentially lead to a misdiagnosis.
2008
- 5 Nov 2008 Z-0608-2009 Unclassified (pre-2012) Terminated 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).
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- 12 May 2008 Z-2054-2009 Unclassified (pre-2012) Terminated 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.
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- 12 May 2008 Z-2055-2009 Unclassified (pre-2012) Terminated 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.
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- 5 Nov 2008 Z-0608-2009 Unclassified (pre-2012) Terminated 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).
Frequently asked questions
How many devices does Hitachi Medical Systems America, Inc. have in the registry?
The registry currently lists 100 devices for Hitachi Medical Systems America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hitachi Medical Systems America, Inc.'s devices?
Among its 50 most recently registered devices, Hitachi Medical Systems America, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Hitachi Medical Systems America, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Hitachi Medical Systems America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Hitachi Medical Systems America, Inc.?
FDA recall records list 45 recalls initiated by Hitachi Medical Systems America, Inc., the most recent initiated on 1 Mar 2021. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Hitachi Medical Systems America, Inc. in the registry?
The most recently registered devices listed for Hitachi Medical Systems America, Inc. include Sirius Starmobile tiara, AIRIS, AIRIS II, MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 and ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM.