Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Symbia T Series is a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BrightView SPECT - Class 2 Recall
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Siemens Symbia E - Class 2 Recall
Symbia E is a multi-purpose SPECT system used 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 588 keV. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia T and Symbia T2 - Class 2 Recall
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia S Series - Class 2 Recall
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), us...
Source: Medical Device Recalls - January 7, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia T Series - Class 2 Recall
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), us...
Source: Medical Device Recalls - January 7, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia Intevo Excel - Class 2 Recall
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for t...
Source: Medical Device Recalls - January 7, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Discovery NM 630 - Class 2 Recall
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. 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 thera...
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Optima NM/CT 640 - Class 2 Recall
Optima NM/CT 640, Models H3100YA, H3100YC. 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 - December 16, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Varicam / VG - Class 2 Recall
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. 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 tomo...
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Brivo NM615 - Class 2 Recall
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. 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...
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts
Philips Medical Systems, Inc. - BrightView XCT System Tomography Computed Emission - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia E - Class 2 Recall
Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia T2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT dia...
Source: Medical Device Recalls - September 30, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia Intevo 2 integrates state-of-the-art SPECT and high quali...
Source: Medical Device Recalls - September 30, 2014 Category: Medical Equipment Source Type: alerts
