18 results
·
87ms
·
Sources: EU EUDAMED, US FDA
EXACT 47
FDA Adverse Event
Malfunction
·CTI PET SYSTEMS (CPS), INC.·Product code ---·August 25, 2004
EXACT ACCEL
FDA Adverse Event
Other
·CTI PET SYSTEMS, INC.·Product code KPS·April 15, 2005
EXACT 47
FDA Adverse Event
Malfunction
·CTI PET SYSTEMS, INC.·Product code KPS·April 8, 2005
ACCEL
FDA Adverse Event
Malfunction
·CTI PET SYSTEMS, INC.·Product code KPS·May 27, 2005
BIOGRAPH LSO DUO
FDA Adverse Event
Malfunction
·CTI PET SYSTEMS, INC.·Product code KPS·June 29, 2005
BIOGRAPH LSO DUO
FDA Adverse Event
Malfunction
·CTI PET SYSTEMS, INC.·Product code KPS·September 2, 2004
SENSATION PET/CT
FDA Adverse Event
Malfunction
·CTI PET SYSTEMS, INC.·Product code KPS·May 13, 2004
REVEAL XL
FDA Adverse Event
Other
·CTI PET SYSTEMS, INC.·Product code KPS·April 19, 2004
BIOGRAPH SENSATION 16
FDA Adverse Event
Malfunction
·CTI PET SYSTEMS, INC.·Product code KPS·May 13, 2004
BIOGRAPH LSO DUO
FDA Adverse Event
Malfunction
·CTI PET SYSTEMS, INC.·Product code KPS·December 10, 2004
SIEMENS ECAT
FDA Adverse Event
Malfunction
·CTI PET SYSTEMS, INC.·Product code KPS·October 8, 1998
ECAT EXACT
FDA Adverse Event
Other
·CTI PET SYSTEMS, INC.·Product code JAK·December 17, 2002
ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America
FDA Recall
Terminated
·CTI PET Systems Inc·Product code KPS·April 5, 2005
Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
FDA Recall
Terminated
·Cti Pet Systems Inc·Product code KPS·October 2, 2003
ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan Hitachi Models: Sceptre and Sceptre XL
FDA Recall
Terminated
·Cti Pet Systems Inc·Product code KPS·March 4, 2003
PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT
FDA Recall
Terminated
·CTI PET Systems Inc·Product code KPS·May 27, 2004
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