Philips North America Llc - Class 2 Recall
728333 Spectral CT 7500 -Computed Tomography X-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2021 Category: Medical Devices Source Type: alerts
Philips North America Llc - Class 2 Recall
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2021 Category: Medical Devices Source Type: alerts
Philips North America Llc - Class 2 Recall
728332 IQon Spectral CT-Computed Tomography X-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - SIGNA PET/MR - Class 2 Recall
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 13, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Revolution CT, Revolution CT ES - Class 2 Recall
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports comp...
Source: Medical Device Recalls - July 9, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Revolution Ascend - Class 2 Recall
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either withor without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysi...
Source: Medical Device Recalls - July 9, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Revolution Apex, Revolution CT Apex Edition. - Class 2 Recall
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, com...
Source: Medical Device Recalls - July 9, 2021 Category: Medical Devices Source Type: alerts
Philips North America Llc - Phillips - Class 2 Recall
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2021 Category: Medical Devices Source Type: alerts
Philips Healthcare (Suzhou) Co., Ltd. - Philips Incisive CT - Class 2 Recall
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2021 Category: Medical Devices Source Type: alerts
Imactis - The IMACTIS CTNAVIGATION system - Class 2 Recall
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 17, 2021 Category: Medical Devices Source Type: alerts
Philips North America Llc - Class 2 Recall
Incisive CT Computed Tomography X-ray System Model: 728143 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 17, 2021 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM - Class 2 Recall
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001) (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 16, 2021 Category: Medical Devices Source Type: alerts
Philips North America, LLC - JETStream Workspace - Class 2 Recall
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2021 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Computed tomography xray system - Class 2 Recall
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Revolution CT ES - Class 2 Recall
Revolution CT ES - 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
