GE Medical Systems, LLC - MRI - Class 2 Recall
Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem 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 reg...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are 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 musculoskel...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer 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 th...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is ...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - MRI - Class 2 Recall
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿ HDx MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood v...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
Nova Biomedical Corporation - Stat Profile Prime Abg AnalyzerStat Profile Prime CCS AnalyzerNova Stat Profile Prime CCS Analyzer - Class 2 Recall
Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 14, 2017 Category: Medical Devices Source Type: alerts
SCANDIUM MURIATICUM Pellet [Hahnemann Laboratories, Inc.]
Updated Date: May 5, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 5, 2017 Category: Drugs & Pharmacology 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
Instradent USA, Inc. - NEODENT CM Intraoral Scanbody - Class 2 Recall
NEODENT CM Intraoral Scanbody, Article Number: 108.139 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 8, 2017 Category: Medical Equipment 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 - Brightview X - Class 2 Recall
882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 17, 2017 Category: Medical Equipment Source Type: alerts
