Philips Medical Systems (Cleveland) Inc - IntelliSpace Portal DX/HX/EX, IntelliSpace Portal IX, and IntelliSpace Portal LX SPECT - Class 2 Recall
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2014 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView XCT BrightView X - Class 2 Recall
Gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. Medical Device for imaging (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2014 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - IntelliSpace Portal - Class 2 Recall
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Helix - Class 2 Recall
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera base...
Source: Medical Device Recalls - March 14, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - VG Hawkeye - Class 2 Recall
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types incl...
Source: Medical Device Recalls - March 14, 2014 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView XCT, BrightView X & BrightView SPECT - Class 2 Recall
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 25, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 - Class 2 Recall
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Me...
Source: Medical Device Recalls - November 21, 2013 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView XCT - Class 2 Recall
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localizati...
Source: Medical Device Recalls - October 29, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Discovery NM/CT 570 c - Class 2 Recall
The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integ...
Source: Medical Device Recalls - August 21, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - VG Hawkeye - Class 1 Recall
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types ...
Source: Medical Device Recalls - July 25, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Discovery NM630 - Class 1 Recall
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 syste...
Source: Medical Device Recalls - July 25, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Helix - Class 1 Recall
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera...
Source: Medical Device Recalls - July 25, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Optima NM/CT 640 - Class 1 Recall
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 25, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Brivo NM615 - Class 1 Recall
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessori...
Source: Medical Device Recalls - July 25, 2013 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView SPECT gamma camera for Emission Computed Tomography - Class 2 Recall
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts
