105 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x; Model Numbers: H48/H83.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code MUJ·May 13, 2010
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·August 17, 2012
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, elec- tron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code MUJ·December 26, 2018
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code MUJ·January 11, 2016
Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart module), Reference/FSCA Identifier: CP-05277, Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·October 31, 2011
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code IYE·December 2, 2016
Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48; Reference/FSCA Identifier: CP-04931; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·July 7, 2011
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·June 18, 2012
Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model H48 Varian Medical Systems, Palo Alto, CA. Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·January 30, 2012
Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·April 4, 2011
Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; Reference/FSCA Identifier: CP-07007, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·December 12, 2011
Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Product Usage: Eclipse Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (Brachytherapy) treatments.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·June 30, 2011
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·January 28, 2013
Eclipse Hypodermic Needle
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FMI·December 20, 2016
Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
FDA Recall
Terminated
·Parker Laboratories, Inc.·Product code IYO·August 6, 2014
Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. Indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code MUJ·October 2, 2008
GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
FDA Recall
Terminated
·GE Healthcare·Product code KPR·March 29, 2007
Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System
FDA Recall
Terminated
·Varian Medical Systems, Palo Alto, CA
911 Hansen Way
Palo Alto CA 94304-1028·Product code MUJ·August 17, 0010
BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FMI·March 7, 2019
Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·May 3, 2011