162 results
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78ms
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Sources: EU EUDAMED, US FDA
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·May 4, 2016
Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·October 1, 2010
Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code ITX·December 19, 2006
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·October 25, 2016
Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·January 7, 2011
Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·January 7, 2011
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·November 14, 2012
CAT-350B TABLE, CPU CONTROL, W/STEP PIVOT
FDA Adverse Event
Injury
·TOSHIBA AMERICAN MEDICAL SYSTEMS, INC.·Product code KXJ·January 26, 2006
DIGITAL FLUOROSCOPY SYSTEM
FDA Adverse Event
Other
·TOSHIBA AMERICAN MEDICAL SYSTEMS, INC.·Product code IZG·October 15, 1998
TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·May 13, 2008
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·April 12, 2016
Aplio 80; SSA-770A; software version 5.5r002
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·November 12, 2007
Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013
Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·January 6, 2010
Toshiba Infinix-i, INFX-8000F The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·December 21, 2010
DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***"
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code MQB·December 29, 2011
Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·January 14, 2016
INFX-8000C Fluoroscopic X-Ray Systems
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code OWB·December 29, 2017
Aquilion 32 CT System; Model number TSX-101 A/K The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·January 8, 2009