14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC-LT2; HSYS-REC-EAMP) Harmonie-S Sleep System (Model HSYS-REC-DUO) VITA/ICU Neurological Monitoring System (Model HSYS-REC-DUO-PPC) Harmonie{-S}{-E} Readers (Models HSYS-RDR-D, HSYS-RDR-T). Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations.
FDA Recall
Terminated
·Stellate Systems·Product code GWQ·April 16, 2009
Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,
FDA Recall
Terminated
·Stellate Systems·Product code GWQ·April 6, 2009
Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,
FDA Enforcement
Class II
·Terminated·Stellate Systems·May 1, 2013
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications
FDA Recall
Terminated
·Bayer Healthcare·Product code DXT·August 2, 2016
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications
FDA Enforcement
Class II
·Terminated·Bayer Healthcare·September 14, 2016
Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018
Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018
Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX
FDA Recall
Terminated
·Medrad Inc·Product code DXT·October 10, 2005
MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code DXT·December 14, 2018
MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
FDA Recall
Terminated
·Medrad Inc dba Bayer R & I·Product code DXT·September 20, 2013
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
FDA Enforcement
Class II
·Terminated·Medrad Inc dba Bayer R&I·June 3, 2015
MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·January 23, 2019