Brainlab AG - Brainlab AG ExacTrac 6.0.x - Class 2 Recall
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2015 Category: Medical Equipment Source Type: alerts
PTW-Freiburg - UNIDOS webline Universal Dosimeter - Class 2 Recall
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosemeter for radiation therapy, diagnostic radiology and health physics. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2015 Category: Medical Equipment Source Type: alerts
Accuray Incorporated - HiArt System - Class 2 Recall
TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717 The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Varian Medical Systems, Inc. Oncology Systems - Clinac High Energy Medical Linear Accelerator - Class 2 Recall
Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System; Model #s: H14, H18, H27, H29, HCX; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereota...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Elekta, Inc. - Medical linear accelerator (with patient imaging) - Class 2 Recall
Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Elekta, Inc. - Oncentra Brachy treatment planning system - Class 2 Recall
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 2015 Category: Medical Equipment Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation - Class 2 Recall
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 28, 2015 Category: Medical Equipment Source Type: alerts
Philips Medical Systems, Inc. - Pinnacle3 Software Version 10.0 - Class 2 Recall
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2015 Category: Medical Equipment Source Type: alerts
Viewray Incorporated - ViewRay Radiation Therapy System - Class 2 Recall
ViewRay System, Radiation Therapy System (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2015 Category: Medical Equipment Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation - Class 2 Recall
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2015 Category: Medical Equipment Source Type: alerts
Elekta, Inc. - Monaco - Class 2 Recall
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2015 Category: Medical Equipment Source Type: alerts
Elekta, Inc. - Elekta Precise Linear Accelerator System - Class 2 Recall
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 11, 2015 Category: Medical Equipment Source Type: alerts
Ion Beam Applications S.A. - adaPT insight (12C), v1.3.2 - Class 2 Recall
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2014 Category: Medical Equipment Source Type: alerts
Mevion Medical Systems, Inc. - Class 2 Recall
MEVION S250, used for proton radiation therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens SimView NT and SimView NT with IDI - Class 2 Recall
Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 21, 2014 Category: Medical Equipment Source Type: alerts
