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
Siemens Medical Solutions USA, Inc - Siemens Mobilett XP Digital Mobile Xray System - Class 2 Recall
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 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
Toshiba American Medical Systems Inc - Toshiba Infinix Solid state xray imager (flat panel/digital imager) - Class 2 Recall
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 2014 Category: Medical Equipment Source Type: alerts
Toshiba American Medical Systems Inc - Solid state xray imager (flat panel/digital imager) - Class 2 Recall
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic stidies used ina interventional setting. K120073. D142204. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 2014 Category: Medical Equipment Source Type: alerts
Fujifilm Medical System USA, Inc. - The MXR35 Xray Generator's. - Class 2 Recall
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2014 Category: Medical Equipment Source Type: alerts
Shimadzu Medical Systems - Shimadzu Digital Radiography XRay System, DAR8000f - Class 2 Recall
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare Optima CT580/Discovery CT590RT scanners - Class 2 Recall
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Xray System - Class 2 Recall
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications. The Innova 3100 system is indicated for use in generating fluoroscopic i...
Source: Medical Device Recalls - March 11, 2014 Category: Medical Equipment Source Type: alerts
Shimadzu Medical Systems - MUX100, MUX100H Xray System - Class 2 Recall
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 8, 2014 Category: Medical Equipment Source Type: alerts
Carestream Health Inc. - Model Kodak 2100 Intraoral XRay System - Class 2 Recall
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2014 Category: Medical Equipment Source Type: alerts
Carestream Health Inc. - Model Kodak 2200 Intraoral XRay System - Class 2 Recall
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2014 Category: Medical Equipment Source Type: alerts
Toshiba American Medical Systems Inc - TSXIOIA: Aquilion 32/64 ONE; System, XRay, Tomography, Computed - Class 2 Recall
" TSX-IOIA: Aquilion 32/64 ONE; System, X-Ray, Tomography, Computed " TSX-101/R: Aquilion RXL; System, X-Ray, Tomography, Computed " TSX-301A: Aquilion One; System X-Ray, Tomography, Computed " TSX-301B: Aquilion Premium; System X-Ray, Tomography, Computed " TSX-302A Aquilion Prime; System X-Ray, Tomography, Computed This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a train...
Source: Medical Device Recalls - March 4, 2014 Category: Medical Equipment Source Type: alerts
Elekta, Inc. - Synergy xray volume imaging (XVI); Elekta Synergy; Elekta Synergy S and XVI - Class 2 Recall
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Precision 500D R&38;F Xray System - Class 2 Recall
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with th...
Source: Medical Device Recalls - February 4, 2014 Category: Medical Equipment Source Type: alerts
