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 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 - 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 - 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 - 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 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 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
Carestream Health, Inc. - Class 2 Recall
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance 64 - Class 2 Recall
Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance iCT - Class 2 Recall
Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance 16 Air - Class 2 Recall
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Ingenuity TF PET/CT (nonRoHS) - Class 2 Recall
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 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). (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - System, xray, tomography, computed25 - Class 2 Recall
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 7, 2019 Category: Medical Devices Source Type: alerts
NEUSOFT MEDICAL SYSTEMS IMP & EX - NeuViz 128 Multislice CT Scanner System - Class 2 Recall
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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 - February 6, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - Biograph Horizon - Class 2 Recall
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2019 Category: Medical Devices Source Type: alerts
