GE Healthcare, LLC - SIGNA Vibrant - Class 2 Recall
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - SIGNA Pioneer - Class 2 Recall
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - SIGNA Architect - Class 2 Recall
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - SIGNA Premier - Class 2 Recall
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2020 Category: Medical Devices Source Type: alerts
Elekta, Inc. - Elekta Unity - Class 2 Recall
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2019 Category: Medical Devices Source Type: alerts
Elekta, Inc. - Elekta Unity - Class 2 Recall
Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2019 Category: Medical Devices Source Type: alerts
Elekta Limited - Elekta Unity - Class 2 Recall
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Multiple Magnetic Resonance Imaging Systems from GE Healthcare - Class 2 Recall
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2019 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - System, Nuclear Magnetic Resonance Imaging - Class 2 Recall
SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest ...
Source: Medical Device Recalls - October 25, 2018 Category: Medical Devices Source Type: alerts
Canon Medical System, USA, INC. - Vantage Titan/Titan 1.5T MRI MPower GX and Vantage Elan 1.5T V4.0 MRI - Class 2 Recall
Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - Discovery MR750w - Class 2 Recall
Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 5481490-2, 5396469-3, 2394952-100, 5911000-3, 5373011-3); F. 3.0T MR750W GEM ENABLED PLU (5352293); G. 3.0T MR750W GEM ENABLED PLUS (5352293, 5499460-10); H. 3.0T MR750W W GEM (5352293, 5911000-3); I. 3.0T MR750W WITH GEM (5...
Source: Medical Device Recalls - September 28, 2018 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase¿ Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial...
Source: Medical Device Recalls - July 20, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Nuclear, Magnetic Resonance Imaging - Class 2 Recall
T5-NT, 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
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195 & 14) Intera 1.5T Pulsar New Model 781295 (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) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 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
