Philips Electronics North America Corporation - XRay, Tomography, Computed - Class 2 Recall
Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 14, 2017 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - XRay, Tomography, Computed - Class 2 Recall
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 14, 2017 Category: Medical Devices Source Type: alerts
Neusoft Medical Systems Co., Ltd. - NeuViz 64 Multislice CT Scanner System - Class 2 Recall
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version 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 - August 29, 2017 Category: Medical Devices Source Type: alerts
Neusoft Medical Systems Co., Ltd. - NeuViz 128 CT Scanner System - Class 2 Recall
Neusoft 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 - August 29, 2017 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Perspective - Class 2 Recall
SOMATOM Perspective, Computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 22, 2017 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Scope Power - Class 2 Recall
SOMATOM Scope Power, Computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 22, 2017 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Scope - Class 2 Recall
SOMATOM Scope, Computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 22, 2017 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView X 3/4 - Class 2 Recall
BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisti...
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView SPECT - Class 2 Recall
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView XCT - Class 2 Recall
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting...
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView X 3/8 - Class 3 Recall
BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisti...
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts
Zimmer Biomet, Inc. - MEDTECH ROSA Spine 1.0.2 - Class 2 Recall
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2017 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance BigBore Radiology CT - Class 2 Recall
Brilliance BigBore Radiology CT - 728244 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance BigBore Oncology CT - Class 2 Recall
Brilliance BigBore Oncology CT - 728243 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Medical Systems Brilliance iCT - Class 2 Recall
Brilliance iCT 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2017 Category: Medical Equipment Source Type: alerts
