Luminex Corporation - ARIES System, ARIES M1 System - Class 2 Recall
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER - Class 2 Recall
Brilliance 64 Model # 728231, computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 7, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Xray Computed Tomography - Class 2 Recall
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 13, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Vereos PET/CT - Class 2 Recall
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, b...
Source: Medical Device Recalls - July 4, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery PET/CT 710 - Class 2 Recall
Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery IQ - Class 2 Recall
Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Optima PET/CT 560, 560FX - Class 2 Recall
Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery Ml - Class 2 Recall
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery PET/CT 610 - Class 2 Recall
Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Discovery Ml DR - Class 2 Recall
Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts
Neusoft Medical Systems Co., Ltd. - NeuViz 64 Multislice CT Scanner System - Class 2 Recall
NeuViz 64 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 - May 22, 2019 Category: Medical Devices Source Type: alerts
Neusoft Medical Systems Co., Ltd. - NeuViz 128 Multislice CT Scanner System - Class 2 Recall
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 - May 22, 2019 Category: Medical Devices Source Type: alerts
Neusoft Medical Systems Co., Ltd. - NeuViz 16 Essence Multislice CT Scanner System - Class 2 Recall
NeuViz 16 Essence 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 - May 22, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Definition AS with Option syngo DE Scan for Single Source - Class 2 Recall
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Definition Edge with Option syngo DE Scan for Single Source - Class 2 Recall
SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2019 Category: Medical Devices Source Type: alerts
