PlainRecalls

Hitachi Medical Systems America Inc

Compiled from official public sources by the editorial team.

17 recalls on record · Latest: Mar 31, 2021

Hitachi Medical Systems America Inc Recall Insight

Hitachi Medical Systems America Inc appears on 17 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.017% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 31, 2021, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 17 entries, severity tagging shows 0 critical, 17 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 17 of 17 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (17). The date window on this page runs from Jul 25, 2012 to Mar 31, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 ultras…

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 flo…

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 Tomograph…

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 cl…

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…

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 …

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 an…

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, …

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 im…

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…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Hitachi Medical Systems America Inc with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.