PlainRecalls

Hitachi Medical Systems America Inc

Compiled from official public sources by the publisher.

17 recalls on record · Latest: Mar 31, 2021

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Agency notice ledger

Federal filing book Hitachi Medical Systems Ame… LIGHT-BOOK · SINGLE-AGENCY

#930 of 14,151 · 17 notices · 0.016% archive

  • BOOK 17 notices
  • RANK #930 of 14,151
  • SHARE 0.016% archive
  • AGENCY FDA Devices (17)
  • CAT medical devices
  • CATS 1 category
  • LATEST Mar 31, 2021
  • PHOTO Actavis Inc

Nearest notice-volume peer: Actavis Inc (0 notice gap)

Hitachi Medical Systems America Inc accounts for about 0.016% of the 104,423-notice archive on 17 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Hitachi Medical Systems Ame… compares to 14,151 recalling firms

Hitachi Medical Systems America Inc ranks 930th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Hitachi Medical Systems Ame… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

17 930th of 14151 higher than 13,196 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Hitachi Medical Systems Ame… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Hitachi Medical Systems America Inc holds about 0.016% of archive notices alongside 17 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Mar 31, 2021

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.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatr
FDA Devices Moderate Feb 26, 2020

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.
FDA Devices Moderate Nov 13, 2019

Hitachi Scenaria Whole-body X-ray CT System
FDA Devices Moderate Aug 29, 2018

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 datasets acquired by the SCENARIA can be post processed by the SCENARIA to provide additional information. Post processing capabilities included in the SCENARIA software include CT angiography (CTA), Multiplanar reconstruct
FDA Devices Moderate Jul 25, 2018

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, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nu
FDA Devices Moderate Mar 7, 2018

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.
FDA Devices Moderate May 24, 2017

Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
FDA Devices Moderate Mar 29, 2017

Hitachi Echelon MRI System
FDA Devices Moderate Mar 29, 2017

Hitachi Oasis MRI System
FDA Devices Moderate Mar 29, 2017

Hitachi Echelon Oval MRI System
FDA Devices Moderate Feb 1, 2017

Hitachi Oasis MRI System - C-Spine Coil
FDA Devices Moderate Aug 17, 2016

Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
FDA Devices Moderate Aug 19, 2015

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 Oasis system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spat
FDA Devices Moderate Sep 10, 2014

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.
FDA Devices Moderate Jun 26, 2013

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 of ionizing radiation. The MR systems produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities.
FDA Devices Moderate Aug 29, 2012

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 determination.
FDA Devices Moderate Jul 25, 2012

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 post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

Hitachi Medical Systems Ame… holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Ad-Tech Medical Instrument Corporation 17 Fhc, Inc. 17 Ge Healthcare It 17 Horiba Instruments, Inc dba Horiba Medical 17

Frequently Asked Questions

How many federal recall notices name Hitachi Medical Systems Ame…? ▼
PlainRecalls indexes 17 distinct federal recall events naming Hitachi Medical Systems America Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Hitachi Medical Systems Ame… sit among other recalling firms? ▼
Hitachi Medical Systems America Inc ranks #930 of 14,151 by distinct recall-event count among 14,151 firms in this archive (93rd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Hitachi Medical Systems Ame…'s notices? ▼
FDA Devices accounts for 17 of this firm's 17 indexed notices.
What product category dominates Hitachi Medical Systems Ame…'s filing book? ▼
Filings for Hitachi Medical Systems America Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Hitachi Medical Systems America Inc: 17 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Hitachi Medical Systems America Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026