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 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

Neusoft Medical Systems Co., Ltd. - NeuViz 64 Multislice CT Scanner System - Class 2 Recall
NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2019 Category: Medical Devices Source Type: alerts

Neusoft Medical Systems Co., Ltd. - NeuViz 128 Multislice CT Scanner System - Class 2 Recall
NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2019 Category: Medical Devices Source Type: alerts

Neusoft Medical Systems Co., Ltd. - NeuViz 16 Essence Multislice CT Scanner System - Class 2 Recall
NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2019 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Edge Plus with Option syngo DE Scan for Single Source - 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Definition AS with Option syngo DE Scan for Single Source - Class 2 Recall
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Definition Edge with Option syngo DE Scan for Single Source - 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Confidence with Option syngo DE Scan for Single Source - 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - NM/CT 850 - Class 2 Recall
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts