Hudson Scientific LLC - iTOVi - Class 2 Recall
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 9, 2018 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - MR Surgical Suite Option - Class 2 Recall
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise ratio, with short scan times. The Signa¿ Excite MR system with Surgical Option 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, T...
Source: Medical Device Recalls - July 24, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Ingenuity Digital PET/CT - Class 2 Recall
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)90002...
Source: Medical Device Recalls - July 20, 2018 Category: Medical Devices Source Type: alerts

Medtronic Neuromodulation - Vectris Trial Screening Lead Kit for Spinal Cord Stimulation - Class 2 Recall
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Faile...
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices Source Type: alerts

TRACE MINERAL CORD (Aluminum, Antimony, Barium, Beryllium, Bismuth, Boron, Bromine, Calcium, Carbon, Cerium, Cesium, Chloride, Chromium, Cobalt, Copper, Dysprosium, Erbium, Europium, Fluoride, Gadolinium, Gallium, Germanium, Gold, Hafnium, Holmium, Indium, Iodine, Iridium, Iron, Lanthanum, Lithium, Lutetium, Magnesium, Manganese, Molybdenum, Neodymium, Nickel, Niobium, Osmium, Palladium, Phosphorus, Platinum, Potassium, Praseodymium, Rhenium, Rhodium, Rubidium, Ruthenium, Samarium, Scandium, Selenium, Silicon, Silver) Liquid [Energique, Inc.]
Updated Date: Jun 28, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 28, 2018 Category: Drugs & Pharmacology Source Type: alerts

Draeger Medical, Inc. - Fabius GS Tiro - Class 2 Recall
Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia mac...
Source: Medical Device Recalls - June 20, 2018 Category: Medical Devices Source Type: alerts

Draeger Medical, Inc. - Fabius GS MRI - Class 2 Recall
Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia mach...
Source: Medical Device Recalls - June 20, 2018 Category: Medical Devices Source Type: alerts

Draeger Medical, Inc. - Fabius GS Premium - Class 2 Recall
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia ...
Source: Medical Device Recalls - June 20, 2018 Category: Medical Devices Source Type: alerts

Zeiss, Carl Inc - Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes. - Class 2 Recall
Carl Zeiss Microscopy for Laser Scanning Microscopes (Cell Observer SD, Laser TIRF and DirectFRAP Laser scanning microscopes are used in cell biology research. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 10, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - Biograph mCT Systems: - Class 2 Recall
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals...
Source: Medical Device Recalls - June 9, 2018 Category: Medical Devices Source Type: alerts

NordicNeuroLab AS - fMRI Hardware System AudioSystem, Version 1.0 - Class 2 Recall
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - Siemens Biograph Horizon - Class 2 Recall
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 25, 2018 Category: Medical Devices Source Type: alerts

Draeger Medical, Inc. - Fabius MRI - Class 1 Recall
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). This device can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or les...
Source: Medical Device Recalls - May 9, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - Biograph Horizon PET/CT - Class 2 Recall
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Philips Ingenuity TF PET/CT Imaging Systems - Class 2 Recall
Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for...
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - Situate Gauze - Class 2 Recall
Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green pouch that you will see on all Situate premium cotton. When activated by magnetic impulses from the scanning devices, the tag resonates a signal that allows for the detection of these cotton disposable. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2018 Category: Medical Devices Source Type: alerts

Ion Beam Applications S.A. - ProteusONE - Class 2 Recall
Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 2018 Category: Medical Devices Source Type: alerts

Ion Beam Applications S.A. - ProteusPLUS - Class 2 Recall
Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 10, 2018 Category: Medical Devices Source Type: alerts

Ion Beam Applications S.A. - Beam Management System - Class 2 Recall
Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 9, 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, dyna...
Source: Medical Device Recalls - February 10, 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 - 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 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 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/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 - 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

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

Carl Zeiss Metrology Inc - Metrotom 800 - Class 2 Recall
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 27, 2018 Category: Medical Devices Source Type: alerts

SCANDONEST 3% PLAIN (Mepivacaine Hydrochloride) Injection, Solution [Septodont, Inc.]
Updated Date: Dec 22, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 22, 2017 Category: Drugs & Pharmacology Source Type: alerts

SCANDONEST 2% L (Mepivacaine Hydrochloride And Levonordefrin) Injection, Solution [Septodont, Inc.]
Updated Date: Dec 19, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 19, 2017 Category: Drugs & Pharmacology 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

SCANDIUM IODATUM Pellet [Hahnemann Laboratories, Inc.]
Updated Date: Nov 21, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 21, 2017 Category: Drugs & Pharmacology 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

Neusoft Medical Systems Co., Ltd. - NeuViz 128 CT Scanner System - Class 2 Recall
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2017 Category: Medical Devices Source Type: alerts

Neusoft Medical Systems Co., Ltd. - NeuViz 64 Multislice CT Scanner System - Class 2 Recall
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2017 Category: Medical Devices Source Type: alerts

Pentax of America Inc - Ultrasound Video Gastroscope, Model EG3670URK - Class 2 Recall
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2017 Category: Medical Devices Source Type: alerts

Pentax of America Inc - Ultrasound Video Gastroscope, Model EG3870UTK - Class 2 Recall
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2017 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - MRI - Class 2 Recall
Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 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 inter...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - MRI - Class 2 Recall
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T 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 be...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - MRI - Class 2 Recall
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners 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, 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 bein...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts

GE Medical Systems, LLC - MRI - Class 2 Recall
Optima MR750 3.0T Product Usage: The Optima MR450 1.5T 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 bein...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts

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 regi...
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 musculoskele...
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 i...
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, bloo...
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 adju...
Source: Medical Device Recalls - April 8, 2017 Category: Medical Equipment Source Type: alerts