Capintec Inc - The Captus 4000e Thyroid Uptake system - Class 2 Recall
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - NM/CT 860 - Class 2 Recall
NM/CT 860 Product Usage: The GE NM/CT 860 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 system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Computed Tomography applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - NM 830 - Class 2 Recall
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for 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 types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery NM/CT 670 CZT - Class 2 Recall
Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT 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 system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Optima NM/CT 640 - Class 2 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 - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - NM/CT 850 - Class 2 Recall
NM/CT 850 Product Usage: The GE NM/CT 850 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 system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - NM/CT 870 DR - Class 2 Recall
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health 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 Medicine (NM) and Computed Tomography (CT) systems, is intended to pr...
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery NM/CT 670 ES - Class 2 Recall
Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health 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 Medicine (NM) and Computed Tomography (CT) systems, is inte...
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - NM/CT 870 CZT - Class 2 Recall
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT 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 system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery NM/CT 670 CZT - Class 2 Recall
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health 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 Medicine (NM) and Computed Tomography (CT) systems, is inte...
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery NM 630 - Class 2 Recall
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for 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 types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
FLUDEOXYGLUCOSE F 18 (Fludeoxyglucose F 18 Injection) Injection [Northland Nuclear Medicine]
Updated Date: Jan 31, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 31, 2019 Category: Drugs & Pharmacology Source Type: alerts
GE Healthcare, LLC - Discover VH/Millennium VG Nuclear Medicine Imaging System - Class 2 Recall
Discover VH/Millennium VG Nuclear Medicine Imaging System (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2019 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 - Precedence 6 , Griffin SPECT/CT Imaging System - Class 2 Recall
Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide ...
Source: Medical Device Recalls - February 4, 2018 Category: Medical Devices Source Type: alerts
