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Hitachi Medical Systems America Inc

36 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Hitachi Oasis MRI System recall (Z-1540-2017)Hitachi Medical Systems America Inc2017-03-23
Hitachi Echelon Oval MRI System recall (Z-1541-2017)Hitachi Medical Systems America Inc2017-03-23
Hitachi Echelon MRI System recall (Z-1542-2017)Hitachi Medical Systems America Inc2017-03-23
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR recall (Z-2366-2015)Hitachi Medical Systems America Inc2015-08-10
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and recall (Z-2564-2014)Hitachi Medical Systems America Inc2014-09-02
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, recall (Z-1559-2013)Hitachi Medical Systems America Inc2013-06-19
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. recall (Z-2254-2012)Hitachi Medical Systems America Inc2012-08-23
Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acq recall (Z-2037-2012)Hitachi Medical Systems America Inc2012-07-19
Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Me recall (Z-2467-2011)Hitachi Medical Systems America Inc2011-06-08
Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2E recall (Z-1616-2010)Hitachi Medical Systems America Inc2010-05-19
Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system p recall (Z-1534-2010)Hitachi Medical Systems America Inc2010-05-04
EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Ver recall (Z-2054-2009)Hitachi Medical Systems America Inc2009-09-09
EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Ver recall (Z-2055-2009)Hitachi Medical Systems America Inc2009-09-09
Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less. recall (Z-1651-2009)Hitachi Medical Systems America Inc2009-07-07
Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less. recall (Z-1652-2009)Hitachi Medical Systems America Inc2009-07-07
Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that pro recall (Z-0608-2009)Hitachi Medical Systems America Inc2009-01-08
Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physici recall (Z-1542-2008)Hitachi Medical Systems America Inc2008-08-23
EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging devi recall (Z-1571-2008)Hitachi Medical Systems America Inc2008-07-24
Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two- recall (Z-1263-2007)Hitachi Medical Systems America Inc2007-09-26
Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL recall (Z-0152-2007)Hitachi Medical Systems America Inc2006-11-04
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J. recall (Z-0029-2007)Hitachi Medical Systems America Inc2006-10-12
Hitachi AIRIS II MRI System recall (Z-1115-06)Hitachi Medical Systems America Inc2006-06-14
Hitachi Altaire Magnetic Resonance Imaging System recall (Z-1103-06)Hitachi Medical Systems America Inc2006-06-10
AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems recall (Z-1104-06)Hitachi Medical Systems America Inc2006-06-10
MRP-7000, AIRIS Magnetic Resonance Imaging Systems recall (Z-1105-06)Hitachi Medical Systems America Inc2006-06-10
Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT) recall (Z-1078-06)Hitachi Medical Systems America Inc2006-06-03
Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT) recall (Z-1079-06)Hitachi Medical Systems America Inc2006-06-03
Magnetic Resonance Imaging Device recall (Z-0910-06)Hitachi Medical Systems America Inc2006-05-31
The AIRIS MR System is an imaging device and is intended to provide the physician with phy recall (Z-0428-06)Hitachi Medical Systems America Inc2006-01-24
The AIRIS II MR System is an imaging device and is intended to provide the physician with recall (Z-0429-06)Hitachi Medical Systems America Inc2006-01-24
Hitachi Altaire Magnetic Resonance Imaging Device. recall (Z-0888-05)Hitachi Medical Systems America Inc2005-06-14
Hitachi AIRIS II Magnetic Resonance Imaging Device recall (Z-0889-05)Hitachi Medical Systems America Inc2005-06-14
Hitachi AIRIS Elite Magnetic Resonance Imaging Device recall (Z-0890-05)Hitachi Medical Systems America Inc2005-06-14
Altaire, Magnetic Resonance Imaging Device. recall (Z-0846-05)Hitachi Medical Systems America Inc2005-05-17
Altaire, Magnetic Resonance Imaging Device. recall (Z-0797-05)Hitachi Medical Systems America Inc2005-05-03
Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Ve recall (Z-1005-04)Hitachi Medical Systems America Inc2004-07-20

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Every clearance here is in the API, with alerts when new ones post.