6 results
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64ms
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Sources: EU EUDAMED, US FDA
RADPRO MOBILE 40KW DIGITAL MOBILE X-RAY SYSTEM
FDA Adverse Event
Malfunction
·SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD S.A·Product code MQB·February 13, 2018
Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
FDA Recall
Terminated
·Canon Inc. 30-2, Shimomaruko 3-chome, Ohta-ku Tokyo Japan·Product code MQB·November 1, 2010
RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
FDA Recall
Terminated
·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·July 13, 2015
EOS, Digital radiography system used in general radiographic examinations.
FDA Recall
Terminated
·Eos Imaging Inc·Product code MQB·February 17, 2015
XiO Radiation Treatment Planning System, XiO Release 4.0.2 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·May 28, 2010
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code KPR·June 15, 2017