80 results
·
84ms
·
Sources: EU EUDAMED, US FDA
ALTAIRE
FDA Adverse Event
Injury
·HITACHI MEDICAL CORP.·Product code LNH·March 23, 2005
AIRIS
FDA Adverse Event
Injury
·HITACHI MEDICAL CORP.·Product code LNH·March 23, 2005
NOBLUS
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code IYN·March 8, 2022
PROSOUND F-75
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code IYN·March 8, 2022
ALTAIRE MR SYSTEM
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code LNH·March 8, 2022
ECHELON OVAL
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code LNH·March 8, 2022
AIRIS ELITE MR SYSTEM
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code LNH·March 8, 2022
CV41 PROBE
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code IYN·March 8, 2022
AIRIS ELITE MR SYSTEM
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code LNH·March 8, 2022
AIRIS II MRI SYSTEM
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code LNH·March 8, 2022
AIRIS ELITE
FDA Adverse Event
Malfunction
·HITACHI MEDICAL CORPORATION·Product code LNH·July 2, 2014
Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code JAK·November 5, 2008
HITACHI ALTAIRE HIGH-FIELD PERFORMANCE
FDA Adverse Event
Other
·HITACHI MEDICAL SYSTEMS AMERICA, INC.·Product code LNH·December 12, 2003
AIRIS II MRI SCANNER
FDA Adverse Event
Malfunction
·HITACHI MEDICAL SYSTEMS AMERICA, INC·Product code LNH·July 25, 2014
OASIS HIGH-FIELD BORE-LESS MR
FDA Adverse Event
HITACHI MEDICAL SYSTEMS AMERICA, INC.·Product code LNI·January 7, 2015
HITACHI AIRIS 2 SYSTEM
FDA Adverse Event
Other
·HITACHI MEDICAL SYSTEMS AMERICA, INC.·Product code LNH·March 29, 1999
Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code JAK·February 21, 2006
ARIETTA 850
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code IYN·March 8, 2022
Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code JAK·February 21, 2006
ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America)
FDA Recall
Terminated
·Siemens Medical Solutions USA Inc·Product code KPS·March 28, 2006