Elekta Inc - Radiation Treatment Planning System - Class 2 Recall
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 9, 2023 Category: Medical Devices Source Type: alerts
Elekta Inc - Monaco RTP System - Class 2 Recall
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2021 Category: Medical Devices Source Type: alerts
Viewray, Inc. - ViewRay Treatment Planning and Delivery System - Class 2 Recall
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 10, 2021 Category: Medical Devices Source Type: alerts
Klarity Medical Products LLC - Klarity Vacuum Bags - Class 2 Recall
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2020 Category: Medical Devices Source Type: alerts
Varian Medical Systems, Inc. - Varian Multileaf Collimator with CSeries Linac - Class 2 Recall
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2020 Category: Medical Devices Source Type: alerts
Elekta Inc - Monaco - Class 2 Recall
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2020 Category: Medical Devices Source Type: alerts
Angiodynamics, Inc. - ORAtrac System - Class 2 Recall
MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2019 Category: Medical Devices Source Type: alerts
Elekta Inc - Monaco RTP System - Class 2 Recall
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and pla...
Source: Medical Device Recalls - September 26, 2019 Category: Medical Devices Source Type: alerts
Elekta Inc - Monaco RTP System - Class 2 Recall
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan...
Source: Medical Device Recalls - September 26, 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
Elekta, Inc. - Monaco RTP System - Class 2 Recall
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2017 Category: Medical Equipment Source Type: alerts
Elekta, Inc. - Monaco RTP System - Class 2 Recall
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2017 Category: Medical Equipment 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
Elekta, Inc. - Oncentra External Beam Treatment Planning Software - Class 2 Recall
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
Elekta, Inc. - Radiation Treatment Planning System - Class 2 Recall
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts
