Angiodynamics, Inc. - OARtrac System - Class 2 Recall
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - 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
Angiodynamics, Inc. - OARtrac System - Class 2 Recall
OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - 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
Viewray, Inc. - MRIdian & MRIdian Linac Radiation Therapy System - Class 2 Recall
MRIdian Linac Radiation Therapy System Model 10000 and 20000 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 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
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
Siemens Medical Solutions USA, Inc - SOMATOM Definition Flash - Class 2 Recall
SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Drive - Class 2 Recall
SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Confidence - Class 2 Recall
SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Force - Class 2 Recall
SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Edge Plus - Class 2 Recall
SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Definition AS - Class 2 Recall
SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Definition Edge - Class 2 Recall
SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2019 Category: Medical Devices Source Type: alerts
Elekta, Inc. - Elekta Unity - Class 2 Recall
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2019 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation - Class 2 Recall
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Vereos PET/CT - Class 2 Recall
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, b...
Source: Medical Device Recalls - July 4, 2019 Category: Medical Devices Source Type: alerts
