Siemens Medical Solutions USA, Inc - Mammomat Revelation - Class 2 Recall
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 19, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - GE Senographe Pristina - Class 2 Recall
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 31, 2019 Category: Medical Devices Source Type: alerts
Agfa N.V. - AGFA Digital Radiography X Ray system DR 800 - Class 2 Recall
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 31, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Centricity PACSIW with Universal Viewer - Class 2 Recall
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requireme...
Source: Medical Device Recalls - June 26, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Centricity Universal Viewer with PACSIW - Class 2 Recall
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product 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 an...
Source: Medical Device Recalls - June 26, 2019 Category: Medical Devices Source Type: alerts
NeuroLogica Corporation - GM85 - Class 2 Recall
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is 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 - May 31, 2019 Category: Medical Devices Source Type: alerts
Hologic, Inc. - IView Contrast Enhanced Digital Mammography, ASY08109 - Class 2 Recall
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 28, 2018 Category: Medical Devices Source Type: alerts
Stephanix - STEPHANIX D2RS Digital Dynamic Remote System - Class 2 Recall
STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 6, 2018 Category: Medical Devices Source Type: alerts
Virtual Imaging, Inc. - RadPRO Mobile 40kW Digital XRay System - Class 2 Recall
RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Centricity PACSIW with Universal Viewer version 5.0.x with PACSIW foundation - Class 2 Recall
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 2, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Centricity Universal Viewer with PACSIW foundation 6.0.x - Class 2 Recall
Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 2, 2018 Category: Medical Devices Source Type: alerts
Beekley Corporation - Mole markers - Class 2 Recall
O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2018 Category: Medical Devices Source Type: alerts
Beekley Corporation - Mammography skin markers - Class 2 Recall
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2018 Category: Medical Devices Source Type: alerts
Beekley Corporation - Scar markers - Class 2 Recall
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare - Centricity PACSIW with Universal Viewer - Class 2 Recall
Centricity PACS-IW with 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 specificatio...
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
