GE Healthcare - Centricity Universal Viewer - Class 2 Recall
Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed a...
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare - GE Healthcare Centricity PACSIW - Class 2 Recall
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Philips ProGrade R1 - Class 2 Recall
digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for all routine radiographic examinations, including specialist area like intensive care, trauma, or pediatric work, excluding mammography. United States only: The Eleva Workspot is not intended for fluoroscopy and angiography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2018 Category: Medical Devices Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using ei...
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - Syngo Imaging - Class 2 Recall
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2018 Category: Medical Devices Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - ASPIRE Cristalle - Class 2 Recall
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2018 Category: Medical Devices Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - Aspire HD - Class 2 Recall
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - CombiDiagnost R90 - Class 2 Recall
CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2018 Category: Medical Devices Source Type: alerts
NeuroLogica Corporation - Samsung GU60A system Digital Xray Imaging Systems - Class 2 Recall
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 26, 2017 Category: Medical Devices Source Type: alerts
Beekley Corporation - 0SPOT Mammography Skin Markers (REF 652) - Class 3 Recall
Beekley Medical 0-SPOT Mammography Skin Markers REF 652 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2017 Category: Medical Devices Source Type: alerts
Merge Healthcare, Inc. - Merge PACS - Class 2 Recall
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 16, 2017 Category: Medical Devices Source Type: alerts
Ge Medical Systems Information T - GE Centricity Web Diagnostic (WebDx) - Class 2 Recall
Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 12, 2017 Category: Medical Equipment Source Type: alerts
