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 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
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
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
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
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 inte...
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 b...
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 bei...
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 bei...
Source: Medical Device Recalls - August 3, 2017 Category: Medical Devices Source Type: alerts
