Philips Medical Systems (Cleveland) Inc - IQon Spectral CT with 4.7.2 software version. - Class 2 Recall
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore Radiology CT - Class 2 Recall
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 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 - March 3, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore Oncology CT - Class 2 Recall
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 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 - March 3, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens Healthcare SOMATOM Go.Now - Class 2 Recall
SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent liter...
Source: Medical Device Recalls - February 25, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens Healthcare SOMATOM Go.Up - Class 2 Recall
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent litera...
Source: Medical Device Recalls - February 25, 2018 Category: Medical Devices Source Type: alerts
Mobius Imaging, LLC - Mobius Imaging Airo Mobile CT System - 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 25, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Ingenuity TF - Class 2 Recall
Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dyn...
Source: Medical Device Recalls - February 10, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Brilliance 64/Ingenuit Family CT Scanners - Class 2 Recall
Philips Brilliance 64 computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Brilliance 64/Ingenuity FamilyCT Scanners - Class 2 Recall
Philips Ingenuity Core computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Brilliance 64/Ingenuity FamilyCT Scanners - Class 2 Recall
Philips Ingenuity CT computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Brilliance 64/Ingenuity FamilyCT Scanners - Class 2 Recall
Philips Ingenuity Core 128 computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare Ingenuity TF PET/CT - Class 2 Recall
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 5, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Precedence 16 , Griffin SPECT/CT Imaging System - Class 2 Recall
Precedence 16 Model # 882350 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
Philips Medical Systems (Cleveland) Inc - BrightView XCT - Class 2 Recall
BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT im...
Source: Medical Device Recalls - February 4, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView and BrightView X - Class 2 Recall
BrightView X, Model #882478 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
