Sedecal S.A. - Mobile wDR motorized portable diagnostic Xray systems. - Class 2 Recall
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 9, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Picture archiving and communications system - Class 2 Recall
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2016 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Centricity PACSIW with Universal Viewer - Class 2 Recall
The 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. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Centricity Universal Viewer Version - Class 2 Recall
The Centricity Universal Viewer Version 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. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2015 Category: Medical Equipment Source Type: alerts
Brainlab AG - Class 2 Recall
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images. (S...
Source: Medical Device Recalls - November 5, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Centricity PACS IW - 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 6, 2015 Category: Medical Equipment Source Type: alerts
Eizo Corporation - RadiForce RX650 - Class 2 Recall
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2015 Category: Medical Equipment Source Type: alerts
Eizo Corporation - RadiForce RX850 - Class 2 Recall
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2015 Category: Medical Equipment Source Type: alerts
Eizo Corporation - RadiForce GX540 - Class 2 Recall
RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - SYNGO IMAGING (VERSION V30 and V31) - Class 2 Recall
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2015 Category: Medical Equipment Source Type: alerts
Beekley Corporation - Bella Blankets - Class 2 Recall
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patient s breast and the imaging receptor plate. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
AGFA Corp. - Drystar Mammo - Class 3 Recall
Drystar Mammo. Display of Mammographic images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - SIEMENS Ysio Max - Class 2 Recall
SIEMENS Ysio Max; 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. The Ysio Max uses integrated or portable digital detectors for generating diagno...
Source: Medical Device Recalls - May 24, 2015 Category: Medical Equipment Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - Fujifilm Aspire HD, Full Field Digital, System - Class 2 Recall
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - AXIOM ARISTOS FX - Class 2 Recall
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2015 Category: Medical Equipment Source Type: alerts
