GE Healthcare, LLC - Revolution CT with Apex Edition CT System - Class 2 Recall
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uMI 550 PET/CT System - Class 2 Recall
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 13, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uCT Computed Tomography XRay System - Class 2 Recall
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 13, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uCT 530, uCT 550 - Class 2 Recall
Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 13, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uCT 530, uCT 550 - Class 2 Recall
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 13, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Revolution Apex, Revolution CT with Apex Edition - Class 2 Recall
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - 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 - October 30, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - SIGNA PET/MR - Class 2 Recall
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - Positron Emission Tomography and Computed Tomography System - Class 2 Recall
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2020 Category: Medical Devices Source Type: alerts
NeuroLogica Corporation - OmniTom / Model NL5000 - Class 2 Recall
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 8, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - UCT 530, UCT 550 - Class 2 Recall
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 28, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - UCT Computed Tomography XRay System - Class 2 Recall
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 28, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - Computed Tomography XRay System - Class 2 Recall
Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 28, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uCT 550 - Class 2 Recall
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 20, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uCT 760 Xray System - Class 2 Recall
uCT 760 System, Computed Tomography X-ray System (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uCT 530 - Class 2 Recall
uCT 530 Computed Tomography X-Ray System (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 1, 2020 Category: Medical Devices Source Type: alerts
