233 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Mobilett XP, mobile X-ray system, Model number 1818454
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZL·March 21, 2007
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code IZL·October 12, 2010
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
FDA Recall
Terminated
·Shimadzu Medical Systems·Product code IZL·October 28, 2011
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IZL·July 10, 2012
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
FDA Recall
Terminated
·Shimadzu Medical Systems·Product code IZL·November 15, 2013
Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Catalog Numbers: 9732719,9733346,81-700-00027, 81-700-00027R, 81700- 00027-100, 81-700-00027-1 OOR, 81-700-00027-120, 81-700-00027-120R, 81700-00027-230, 81-700-00027-230R, 81-700-00027GER, 81-700-00027GERR Intended use: Designed for 2D fluoroscopic and 3D imaging and is intended to be used by a physician benefits from 2D and 3D information of anatomic structures with high x-ray attenuation such as bony and metallic objects.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code IZL·October 15, 2010
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is 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. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code IZL·June 11, 2013
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
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
FDA Recall
Terminated
·GE Healthcare·Product code IZL·December 19, 2014
Powermobil Mobile X-Ray System
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZL·August 1, 2005
Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI
FDA Recall
Terminated
·GE Medical Systems LLC·Product code IZL·December 21, 2006
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code IZL·March 27, 2007
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code IZL·March 27, 2007
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
FDA Recall
Terminated
·Carestream Health Inc.·Product code IZL·June 19, 2013
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
FDA Recall
Terminated
·Carestream Health, Inc.·Product code IZL·July 26, 2013
Mobile Diagnostic X-Ray System with Digital Panel
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code IZL·November 28, 2012
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
FDA Recall
Terminated
·NeuroLogica Corporation·Product code IZL·May 6, 2019
Siremobil Compact Mobile X-Ray System
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZL·August 1, 2005
Arcadis Varic Mobile X-Ray System
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZL·August 1, 2005
BV212 Mobile X-Ray System
FDA Recall
Terminated
·Philips Medical Systems Sales & Service Region No. America·Product code IZL·July 20, 2004