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
GE Healthcare, LLC - Centricity Universal Viewer with PACSIW - Class 2 Recall
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution an...
Source: Medical Device Recalls - June 26, 2019 Category: Medical Devices Source Type: alerts
Elekta Instrument AB - Leksell GammaPlan 11.1 - Class 2 Recall
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2019 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - UniCel DxH 600 Coulter Cellular Analysis System - Class 1 Recall
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel¿ DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole B...
Source: Medical Device Recalls - May 24, 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 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
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 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 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
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
Philips Medical Systems (Cleveland) Inc - Brilliance 16 Air - Class 2 Recall
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance iCT - Class 2 Recall
Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2019 Category: Medical Devices Source Type: alerts
