Philips Medical Systems (Cleveland) Inc - BrightView - Class 2 Recall
BrightView Model 882480 Product Usage: 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 - February 4, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Precedence 6 , Griffin SPECT/CT Imaging System - Class 2 Recall
Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide ...
Source: Medical Device Recalls - February 4, 2018 Category: Medical Devices Source Type: alerts
Brainlab AG - Mobius Imaging AIRO CT - Class 2 Recall
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg). (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance iCT SP, Brilliance iCT - Class 2 Recall
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance iCT - Class 2 Recall
Brilliance iCT - Model 728306 Computed Tomography X-ray systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare Brilliance iCT - Class 2 Recall
Philips Healthcare Brilliance iCT computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare IQon Spectral CT - Class 2 Recall
Philips Healthcare IQon Spectral CT computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare Brilliance iCT SP - Class 2 Recall
Philips Healthcare Brilliance iCT SP computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2018 Category: Medical Devices Source Type: alerts
Zimmer Biomet, Inc. - ROSA Spine 1.0.2 - Class 2 Recall
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons 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 lumber vertebrae with a posterior approach. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2017 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia Intevo 16 - Class 2 Recall
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either...
Source: Medical Device Recalls - November 17, 2017 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia Intevo 6 - Class 2 Recall
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either ...
Source: Medical Device Recalls - November 17, 2017 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - XRay, Tomography, Computed - Class 2 Recall
Philips Healthcare Brilliance iCT 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 Core 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 Brilliance 64 System, 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 Core128 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
