Soft Computer Consultants, Inc. - SoftCytogenetics - Class 2 Recall
SoftCytogenetics (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2021 Category: Medical Devices Source Type: alerts
Soft Computer Consultants, Inc. - SoftGenomics - Class 2 Recall
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 20, 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
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 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
Abbott Laboratories Inc. (St Jude Medical) - WorkMate Claris System, Model H700123 - Class 2 Recall
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2021 Category: Medical Devices Source Type: alerts
Abbott Laboratories Inc. (St Jude Medical) - WorkMate Claris System Display, Model H700124 - Class 2 Recall
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2021 Category: Medical Devices Source Type: alerts
Medtronic Inc. - MiniMed 670G Insulin Infusion Pump - Class 2 Recall
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. This data can be uploaded to a computer for analysis of historical glucose values. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 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
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 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
Boston Scientific Corporation - VisualICE MRI MCP - Class 2 Recall
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 24, 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
