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 go.All - Class 2 Recall
SOMATOM go.All (Model #11061630), 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 - Class 2 Recall
SOMATOM go.All, Model No. 11061638 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.Top, Model No. 11061648 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 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 - 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
