Hitachi Medical Systems America Inc
Twinsburg, OH
This page shows every FDA and USDA recall linked to Hitachi Medical Systems America Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
45
Total Recalls
2004
First Recall
2021
Most Recent
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonog...
Mar 1, 2021
· Device
Terminated
UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for dia...
Jan 31, 2020
· Device
Terminated
Hitachi Scenaria Whole-body X-ray CT System
Oct 16, 2019
· Device
Terminated
Hitachi Scenaria CT system
Product Usage:
The SCENARIA CT system is indicated for head, whole body, cardiac a...
Jun 29, 2018
· Device
Terminated
Hitachi Oasis MRI system
Product Usage:
Hitachi MR system is an imaging device and is intended to provide the...
Jun 18, 2018
· Device
Terminated
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system ev...
Oct 20, 2017
· Device
Terminated
Arietta 70 Ultrasound System
Intended for use by trained personnel (doctor, sonographer. etc.) for the diagno...
May 2, 2017
· Device
Terminated
Hitachi Echelon Oval MRI System
Mar 23, 2017
· Device
Terminated
Hitachi Echelon MRI System
Mar 23, 2017
· Device
Terminated
Hitachi Oasis MRI System
Mar 23, 2017
· Device
Terminated
Hitachi Oasis MRI System - C-Spine Coil
Jan 6, 2017
· Device
Terminated
Oasis Coil Extension Cable used with Hitachi Oasis MRI System
Product Usage:
The Oasis MR system is an imagin...
Aug 10, 2015
· Device
Terminated
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Jun 30, 2015
· Device
Terminated
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to prov...
Sep 2, 2014
· Device
Terminated
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box.
The Echelon, Echelon Oval and O...
Jun 19, 2013
· Device
Terminated
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices.
Product Usage:
The...
Aug 23, 2012
· Device
Terminated
Hitachi Scenaria CT System Software
Product Usage: The Scenaria system is indicated to acquire axial volumes...
Jul 19, 2012
· Device
Terminated
Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 5...
Jun 8, 2011
· Device
Terminated
Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO
May 19, 2010
· Device
Terminated
Hitachi Oasis Magnetic Resonance Scanners Software V1.0C
The intended use: The MR system produces transverse,...
May 4, 2010
· Device
Terminated
EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-...
Sep 9, 2009
· Device
Terminated
EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners,
DICOM Option EZU-FC6, Software Versions: V11-01, V...
Sep 9, 2009
· Device
Terminated
Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less.
Jul 7, 2009
· Device
Terminated
Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
Jul 7, 2009
· Device
Terminated
Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectiona...
Jan 8, 2009
· Device
Terminated
Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiologica...
Aug 23, 2008
· Device
Terminated
EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to prov...
Jul 24, 2008
· Device
Terminated
Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive on...
Sep 26, 2007
· Device
Terminated
Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-...
Nov 4, 2006
· Device
Terminated
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Oct 12, 2006
· Device
Terminated
Hitachi AIRIS II MRI System
Jun 14, 2006
· Device
Terminated
MRP-7000, AIRIS Magnetic Resonance Imaging Systems
Jun 10, 2006
· Device
Terminated
Hitachi Altaire Magnetic Resonance Imaging System
Jun 10, 2006
· Device
Terminated
AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
Jun 10, 2006
· Device
Terminated
Hitachi Emission Computed Tomography System
Hitachi CX-4 CT (including SceptreP3 PET-CT)
Jun 3, 2006
· Device
Terminated
Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
Jun 3, 2006
· Device
Terminated
Magnetic Resonance Imaging Device
May 31, 2006
· Device
Terminated
The AIRIS MR System is an imaging device and is intended to provide the physician with physiological and clini...
Jan 24, 2006
· Device
Terminated
The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and cl...
Jan 24, 2006
· Device
Terminated
Hitachi Altaire Magnetic Resonance Imaging Device.
Jun 14, 2005
· Device
Terminated
Hitachi AIRIS II Magnetic Resonance Imaging Device
Jun 14, 2005
· Device
Terminated
Hitachi AIRIS Elite Magnetic Resonance Imaging Device
Jun 14, 2005
· Device
Terminated
Altaire, Magnetic Resonance Imaging Device.
May 17, 2005
· Device
Terminated
Altaire, Magnetic Resonance Imaging Device.
May 3, 2005
· Device
Terminated
Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM S...
Jul 20, 2004
· Device
Terminated