Siemens Medical Solutions USA, Inc - Syngo.via Picture archiving and communication system - Class 2 Recall
Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines ...
Source: Medical Device Recalls - March 28, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Syngo.x Picture archiving and communication system - Class 2 Recall
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines mi...
Source: Medical Device Recalls - March 28, 2017 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Mammomat Inspiration - Class 2 Recall
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 1, 2017 Category: Medical Equipment 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 - December 9, 2016 Category: Medical Equipment Source Type: alerts
Merge Healthcare, Inc. - RadSuite (by Merge Healthcare) - Class 2 Recall
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k)...
Source: Medical Device Recalls - November 19, 2016 Category: Medical Equipment Source Type: alerts
Merge Healthcare, Inc. - Merge PACS software. - Class 2 Recall
Merge PACS software. Product Usage: 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 - November 18, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - YSIO MAX - Class 2 Recall
YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2016 Category: Medical Equipment Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner (FDR1000BPY) - Class 2 Recall
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), 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 - August 31, 2016 Category: Medical Equipment Source Type: alerts
Avid Medical, Inc. - AVID TruCustom - Class 2 Recall
MAMMOGRAPHY (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2016 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - Imagecast PACS 3.5 and 3.6 - Class 2 Recall
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may o...
Source: Medical Device Recalls - July 29, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - SYNGO Breast Care - Class 2 Recall
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 1, 2016 Category: Medical Equipment Source Type: alerts
Carestream Health Inc - CARESTREAM Image Suite - Class 2 Recall
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in...
Source: Medical Device Recalls - May 3, 2016 Category: Medical Equipment Source Type: alerts
Carestream Health Inc - CARESTREAM Image Suite - Class 2 Recall
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/C...
Source: Medical Device Recalls - May 3, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Picture Archiving and Communication System - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 8, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Syngo Dynamics - Class 2 Recall
Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2016 Category: Medical Equipment Source Type: alerts
