Manufacturer

Hitachi Medical Systems America Inc

17 recalls in our database name Hitachi Medical Systems America Inc as the manufacturing or recalling firm.

What the numbers show

Total: 17
Critical: 0
Severe: 2
Most recent: 2021-03-31

Of the 17 recalls from Hitachi Medical Systems America Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (12%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

SevereFDA (Devices)·Z-1282-2021·2021-03-31
Hitachi Arietta 850 Ultrasound System Recalled for Acoustic Output Error
Hitachi Medical Systems America Inc. is recalling Arietta 850 ultrasound systems with specific software versions due to an error that can cause acoustic output to exceed regulatory limits.
Product
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.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2020·2020-02-26
Hitachi Medical Systems Recalls 18 Ultrasound Probes Due to Mis-Wiring
Hitachi Medical Systems America Inc is recalling 18 UST-2265-2 ultrasound probes due to potential mis-wiring that may cause decreased sensitivity and lower peak velocity readings.
Product
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 Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0271-2020·2019-11-13
Hitachi Scenaria CT System Recalled for Potential Cable Detachment
Hitachi Medical Systems America Inc is recalling 39 Scenaria Whole-body X-ray CT Systems because cables to the controller unit may not be affixed properly, creating a risk of detachment during scanning.
Product
Hitachi Scenaria Whole-body X-ray CT System
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-2839-2018·2018-08-29
Hitachi Scenaria CT System Recalled for Table Motion Hazard
Hitachi is recalling one Scenaria CT system in Texas because the patient table failed to stop and contacted the gantry, posing a risk of injury.
Product
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 either axial, helical, gated or dynamic modes. The volume dat
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2479-2018·2018-07-25
Hitachi Oasis MRI Systems Recalled for Exposed Belt Hazard
Hitachi Medical Systems America Inc is recalling 264 Oasis MRI systems because an exposed stainless steel belt can cause finger cuts.
Product
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 radiation. The Oasis system produces transverse, corona
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0816-2018·2018-03-07
Hitachi Ultrasound Transducer Recalled for Electrical Shock Hazard
Hitachi Medical Systems America Inc is recalling 55 ultrasound transducers (Model UST-5550-R) because they may not have adequate protection against electrical shock hazards.
Product
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.
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-2090-2017·2017-05-24
Hitachi Arietta 70 Ultrasound System Recalled for Weak Arm Mounting Mechanism
Hitachi Medical Systems America Inc is recalling 77 Arietta 70 Ultrasound Systems because the arm mounting mechanism was insufficiently strong and required redesign.
Product
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1541-2017·2017-03-29
Hitachi Echelon Oval MRI System Recalled for Image Data Errors
Hitachi Medical Systems America Inc is recalling 25 Hitachi Echelon Oval MRI Systems because image data transferred to workstations showed errors on the slice position reference image.
Product
Hitachi Echelon Oval MRI System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1540-2017·2017-03-29
Hitachi Oasis MRI System Recalled for Image Data Transfer Errors
Hitachi Medical Systems America Inc is recalling 210 Hitachi Oasis MRI Systems because image data transferred to workstations showed errors on the slice position reference image.
Product
Hitachi Oasis MRI System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1542-2017·2017-03-29
Hitachi Echelon MRI System Recalled for Image Data Transfer Errors
Hitachi Medical Systems America Inc is recalling 68 Hitachi Echelon MRI Systems because image data transferred to workstations showed errors on the slice position reference image.
Product
Hitachi Echelon MRI System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2017·2017-02-01
Hitachi Oasis MRI C-Spine Coil Recalled Due to Overheating Balun
Hitachi Medical Systems America Inc is recalling 180 Hitachi Oasis MRI System C-Spine Coils because the coil balun was found to be hot to the touch after an exam.
Product
Hitachi Oasis MRI System - C-Spine Coil
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2392-2016·2016-08-17
Hitachi Scenaria CT System Recalled for Power Supply Failure Risk
Hitachi Medical Systems America is recalling 33 Scenaria CT systems because centrifugal force may cause the power supply to fail, potentially requiring patients to be rescanned.
Product
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-2366-2015·2015-08-19
Hitachi Oasis MRI Coil Extension Cable Recalled for Overheating Burn Hazard
Hitachi Medical Systems America Inc is recalling 173 Oasis Coil Extension Cables used with MRI systems because they may overheat and cause burns.
Product
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-invasively and without the use of ionizing radiation. The O
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2564-2014·2014-09-10
Hitachi Echelon Oval MRI Systems Recalled for Gradient Coil Overheating
Hitachi Medical Systems America Inc is recalling 39 Echelon Oval MRI systems because the gradient coil can overheat and become a burn hazard.
Product
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 ionizing radiation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1559-2013·2013-06-26
Hitachi Recalls Echelon and Oasis MR Imaging Systems Due to Software Error
Hitachi is recalling 45 Echelon, Echelon Oval, and Oasis MR imaging systems due to a software error that can cause image data loss during simultaneous scanning and processing.
Product
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 information, obtained non-invasively and without the use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2254-2012·2012-08-29
Hitachi MRI Software Recall for Image Orientation Error
Hitachi is recalling MRI software due to a defect that may reverse the orientation of the first image in a dataset.
Product
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 clinical information that can be useful in diagnosis determ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2037-2012·2012-07-25
Hitachi Scenaria CT System Software Recall for Reconstruction Error
Hitachi is recalling Scenaria CT System software due to a defect that may cause incomplete image reconstruction, potentially resulting in missing diagnostic data.
Product
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 modes. The volume datasets acquired by the Scenaria can be
Category
Medical Device
Distribution
Distributed nationwide