Varian Medical Systems, Inc. - Eclipse(TM) Treatment Planning System - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 25, 2019 Category: Medical Devices Source Type: alerts

Theragenics Corporation - Theragenics Brachytherapy needles - Class 2 Recall
Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2018 Category: Medical Devices Source Type: alerts

Bard Brachytherapy, Inc. - Bard BrachySource Seed Implants - Class 2 Recall
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2018 Category: Medical Devices Source Type: alerts

Varian Medical Systems, Inc. - Eclipse Treatment Planning System version 13.MR2 - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - Eclipse Treatment Planning System - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2016 Category: Medical Equipment Source Type: alerts

Philips Medical Systems - PINNACLE3 RADIATION THERAPY PLANNING SYSTEM - Class 2 Recall
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Product Usage: The Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle Radiation Treatment Planning System incorporates a number of fully integrated subsystems. The full Pinnacle Radiation Treatment Planning System software package provides planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy technique. The Pinnacle3 Radiation Therapy Planning System assists the c...
Source: Medical Device Recalls - February 3, 2016 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - XiO Radiation Treatment Planning System - Class 2 Recall
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2015 Category: Medical Equipment Source Type: alerts

Varian Medical Systems Inc - VariSource iX series - Class 2 Recall
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Source Production & Equipment Inc - M19 (Iridium 192) - Class 2 Recall
M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2015 Category: Medical Equipment Source Type: alerts

Varian Medical Systems Inc - Surface Applicator Set with Leipzigstyle Cone - Class 2 Recall
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 24, 2015 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - XiO RPT System - Class 2 Recall
XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 14, 2014 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - XiO RTP System - Class 2 Recall
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2014 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - XiO RTP System - Class 2 Recall
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2014 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - Class 2 Recall
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 25, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - Segmented Cylinder Applicator Set - Class 2 Recall
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Eclipse Treatment Planning System - Class 2 Recall
Varian brand Varian Eclipse" Treatment Planning System for Radiotherapy; 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. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - Rectal Retractor - Class 2 Recall
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 1, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - White Acetal Titanium Rectal Retractor - Class 2 Recall
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 1, 2013 Category: Medical Equipment Source Type: alerts