10 results
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47ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain View, CA
FDA Recall
Terminated
·Hansen Medical Inc·Product code DXX·October 19, 2009
Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria.
FDA Recall
Terminated
·Hansen Medical Inc·Product code DRA·May 21, 2008
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code JAQ·August 9, 2013
Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.
FDA Recall
Terminated
·Varian Medical Systems·Product code JAQ·April 14, 2005
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
FDA Recall
Terminated
·Hansen Medical Inc·Product code DXX·March 18, 2015
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
FDA Recall
Terminated
·Hansen Medical Inc·Product code DXX·March 25, 2016
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.
FDA Recall
Terminated
·Hansen Medical Inc·Product code DXX·December 4, 2014
BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Palo Alto, California 94304-1038. Used to plan radiotherapy treatments for patients with malignant or benign diseases. In addition, the module is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code MUJ·August 11, 2010
Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304.
FDA Recall
Terminated
·Varian Medical Systems Inc
3100 Hansen Way
M/S E-210
Palo Alto CA 94304·Product code IYE·March 30, 2005
Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability
FDA Recall
Terminated
·Varian Medical Systems Inc
3100 Hansen Way
M/S E-210
Palo Alto CA 94304-1030·Product code IYE·February 4, 2005