Siemens Medical Solutions USA, Inc - SOMATOM go.Top - Class 2 Recall
SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is 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. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by ...
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.Up - Class 2 Recall
SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is 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. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by p...
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM - Class 2 Recall
SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is 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. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined ...
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM - Class 2 Recall
SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is 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. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined b...
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.Now - Class 2 Recall
SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is 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. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by...
Source: Medical Device Recalls - July 3, 2019 Category: Medical Devices Source Type: alerts
Hitachi America, Ltd., Power Systems Division - HITACHI PROBEATV - Class 2 Recall
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2019 Category: Medical Devices Source Type: alerts
Elekta, Inc. - Elekta Unity - Class 2 Recall
Elekta Unity systems Product Usage: 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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2019 Category: Medical Devices Source Type: alerts
Viewray, Inc. - MRIdian Linac Radiation Therapy System - Class 2 Recall
MRIdian Linac Radiation Therapy System, Model 20000. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2019 Category: Medical Devices Source Type: alerts
Brainlab AG - Radiation Therapy Treatment Planning System - Class 2 Recall
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 22, 2019 Category: Medical Devices Source Type: alerts
Elekta Limited - Elekta Unity - Class 2 Recall
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: 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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Vereos PET/CT - Class 2 Recall
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines 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, cardiol...
Source: Medical Device Recalls - November 1, 2018 Category: Medical Devices Source Type: alerts
Mevion Medical Systems, Inc. - MEVION S250/MEVION S250i - Class 2 Recall
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 12, 2018 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation - Class 2 Recall
RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 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 us...
Source: Medical Device Recalls - July 27, 2018 Category: Medical Devices Source Type: alerts
Elekta, Inc. - HexaPOD evo RT Couch Top (HexaPOD evo Module) - Class 2 Recall
HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 25, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Ingenuity Digital PET/CT - Class 2 Recall
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (...
Source: Medical Device Recalls - July 20, 2018 Category: Medical Devices Source Type: alerts
