Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2018 Category: Medical Devices Source Type: alerts
Medtronic Neurosurgery - StrataMR Adjustable Valves & Shunts - Class 1 Recall
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adj...
Source: Medical Device Recalls - April 8, 2017 Category: Medical Equipment Source Type: alerts
Merge Healthcare, Inc. - Merge Healthcare CADstream - Class 2 Recall
CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 23, 2016 Category: Medical Equipment Source Type: alerts
Bayer Healthcare - MEDRAD MRXerion MR Injection System - Class 2 Recall
Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to o...
Source: Medical Device Recalls - July 20, 2016 Category: Medical Equipment Source Type: alerts
Toshiba American Medical Systems Inc - Vantage Titan 3T MRI System - Class 2 Recall
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performance, we are crossing over to Toshiba s new 3T Conform Technology. Vantage Titan 3T features a patient aperture of 71 cm and Pianissimo noise reduction technology. It comes with a new, fully functional, state-of-the-art interfac...
Source: Medical Device Recalls - July 7, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - MAGNETOM Aera/Skyra - Class 2 Recall
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2016 Category: Medical Equipment Source Type: alerts
