Xstrahl Limited - Concerto - Class 2 Recall
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 27, 2021 Category: Medical Devices Source Type: alerts
Nucletron BV - Flexitron remotecontrolled radionuclide applicator system - Class 2 Recall
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 3, 2020 Category: Medical Devices Source Type: alerts
Riverpoint Medical, LLC - RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style - Class 3 Recall
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2019 Category: Medical Devices Source Type: alerts
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 t...
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
