GE Healthcare - GE Healthcare Proteus XR/a - Class 2 Recall
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license - Class 2 Recall
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. 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 mean...
Source: Medical Device Recalls - January 17, 2015 Category: Medical Equipment Source Type: alerts
Carestream Health, Inc. - CARESTREAM DIRECTVIEW CR - Class 2 Recall
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2014 Category: Medical Equipment Source Type: alerts
Philips Medical Systems, Inc. - Sedecal MobileDiagnost wDR - Class 2 Recall
Intended for 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 the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Mammomat Inspiration system - Class 2 Recall
Mammomat Inspiration system: Product Usage: 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 - December 7, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens Mammomat Inspiration mammography systems - Class 2 Recall
Siemens Mammomat Inspiration mammography systems. 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 - October 18, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens Ysio Max system - Class 2 Recall
Siemens Ysio Max system 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. The Ysio Max uses integrated or portable digital detectors...
Source: Medical Device Recalls - October 3, 2014 Category: Medical Equipment Source Type: alerts
Brainlab AG - Brainlab Diital Lightbox - Class 2 Recall
The Patient Data Manager (Digital Lightbox) 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 31, 2014 Category: Medical Equipment Source Type: alerts
AGFA Corp. - AGFA Digital Radiography XRay system DXD 100 - Class 2 Recall
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Proteus XR/a - Class 2 Recall
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Revolution XR/d. - Class 2 Recall
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2014 Category: Medical Equipment Source Type: alerts
Beekley Corporation - Beekley Spots Light Image OSpots - Class 3 Recall
Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 14, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Class 2 Recall
Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio 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.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or...
Source: Medical Device Recalls - June 5, 2014 Category: Medical Equipment Source Type: alerts
Hologic, Inc. - Hologic Selenia Full Field Digital Mammography System - Class 2 Recall
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 4, 2014 Category: Medical Equipment Source Type: alerts
Hologic, Inc. - Hologic MIV Mammography System - Class 2 Recall
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 4, 2014 Category: Medical Equipment Source Type: alerts
