Philips Medical Systems, Inc. - Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software - Class 2 Recall
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, X...
Source: Medical Device Recalls - April 25, 2014 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiolog - Class 2 Recall
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2014 Category: Medical Equipment Source Type: alerts
Velocity Medical Solutions, LLC - DICOM - Class 2 Recall
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge - Class 2 Recall
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2014 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology - Class 2 Recall
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 22, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare It - Merge (Cedara) Mammo - Class 2 Recall
Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital. Productivity-Enhancing Second Console Workstations - Workstations designed to perform automated, routine tasks such as image ...
Source: Medical Device Recalls - January 15, 2014 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - GE Centricity PACS (Versions 3.1.1.2 or later) - Class 2 Recall
Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. the workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2014 Category: Medical Equipment Source Type: alerts
Mckesson Information Solutions LLC - McKesson Radiology - Class 2 Recall
McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2013 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - GE Centricity Web - Class 2 Recall
The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser tec...
Source: Medical Device Recalls - December 6, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Vivid E9 ultrasound system - Class 2 Recall
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high perfor...
Source: Medical Device Recalls - November 22, 2013 Category: Medical Equipment Source Type: alerts
Philips Healthcare Informatics, Inc. - IntelliSpace PACS - Class 2 Recall
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, pro...
Source: Medical Device Recalls - November 14, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare It - GE Centricity PACS - Class 2 Recall
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 31, 2013 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - GE Centricity PACSIW - Class 2 Recall
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited t...
Source: Medical Device Recalls - October 31, 2013 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Ingenuity TF PET/CT - Class 2 Recall
Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and ...
Source: Medical Device Recalls - October 26, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare It - Centricity Cardio Imaging - Class 2 Recall
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and t...
Source: Medical Device Recalls - October 22, 2013 Category: Medical Equipment Source Type: alerts
