Siemens Medical Solutions USA Inc. - Biograph Mobile - Class 2 Recall
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 1, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Biograph Mobile - Class 2 Recall
Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 1, 2017 Category: Medical Equipment Source Type: alerts
Tosoh Smd Inc - Keyspan Adapter - Class 2 Recall
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port...
Source: Medical Device Recalls - February 23, 2017 Category: Medical Equipment Source Type: alerts
Soft Computer Consultants, Inc. - Softbank II 23.1.2.8 25.3.0.0 - Class 2 Recall
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 27, 2017 Category: Medical Equipment Source Type: alerts
Soft Computer Consultants, Inc. - Softbank 25.5.2.025.5.3.1 - Class 2 Recall
Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 27, 2017 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips IQon Spectral CT - Class 2 Recall
IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT 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. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset composed of data from a higher-energy detected x-ray spectrum and a lower-energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy depende...
Source: Medical Device Recalls - January 12, 2017 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Medical Systems Brilliance iCT - Class 2 Recall
Brilliance iCT 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Biograph mCT S(64)4R - Class 2 Recall
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - BIOGRAPH mCT 20 Excel - Class 2 Recall
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Bio mCTS(40) 3R4R Upgrade - Class 2 Recall
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of d...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Biograph mCT Flow 404R - Class 2 Recall
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determini...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Biograph mCT X3R - Class 2 Recall
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining var...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Biograph mCT Flow Edge4R - Class 2 Recall
Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determi...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Biograph mCT X4R - Class 2 Recall
Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining var...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Biograph mCT S(40)4R - Class 2 Recall
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
