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Sources: EU EUDAMED, US FDA
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Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·September 28, 2012
Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW).
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·October 3, 2009
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 2, 2013
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 13, 2013
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 6, 2013
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 28, 2012
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 24, 2012
Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips Nuclear Medicine, Milpitas, CA 95035
FDA Recall
Terminated
·Phillips Nuclear Medicine·Product code KPS·September 28, 2007
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. Philips Medical Systems, Cleveland, OH 44143. (The product is a software application that is installed in Philips Medical System CT scanners.)
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 10, 2007
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Brilliance CT scanners using software versions 2.0 through V 2.2.5 and all EBW workstations using software versions 2.0 through V3.5.2. Philips Medical Systems, Cleveland, OH 44143. (The product is a software application that is installed in Philips Medical System CT scanners.)
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 10, 2007
Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data.
FDA Recall
Terminated
·Philips Medical Systems·Product code LLZ·September 15, 2011
Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #455011202691 for Computed Tomography (CT); Model #455011002031 for Nuclear Medicine (NM). The "Extended Brilliance Workspace (EBW)" Dental Application v4.0 and v4.0.1 is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·April 27, 2009
TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·January 28, 2009
TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an accessory for the GEMINI PET/CT Systems running CT software versions 3.5.x. , CT host 2.2. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·February 19, 2009
TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase for use on the GEMINI GXL 16 Slice PET/CT System (contains EBW 455011002031 as an accessory), Catalog #882410, Model Number: 4535 679 71891. CT host. 2.2. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·February 19, 2009
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
FDA Recall
Terminated
·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
FDA Recall
Terminated
·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017
CORE Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
FDA Recall
Terminated
·ConMed Corporation·Product code GBW·June 27, 2016
CORE Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
FDA Recall
Terminated
·ConMed Corporation·Product code GBW·June 27, 2016
Peritoneal Lavage Kits, Model number AK-09000
FDA Recall
Terminated
·Arrow International Inc·Product code GBW·August 2, 2004