Accuray Incorporated
15 recalls on record · Latest: Feb 5, 2025
FDA Devices Moderate Feb 5, 2025
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The Cy…
FDA Devices Moderate Mar 24, 2021
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tu…
FDA Devices Moderate Jan 13, 2021
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation ther…
FDA Devices Moderate Jun 12, 2019
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201…
FDA Devices Moderate Nov 14, 2018
CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery a…
FDA Devices Moderate Sep 26, 2018
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
FDA Devices Moderate Jan 3, 2018
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he p…
FDA Devices Moderate Jan 3, 2018
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he pla…
FDA Devices Moderate Jan 3, 2018
TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he pl…
FDA Devices Moderate Dec 28, 2016
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment pla…
FDA Devices Moderate Feb 17, 2016
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is in…
FDA Devices Moderate Nov 26, 2014
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment plan…
FDA Devices Moderate Feb 5, 2014
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic…
FDA Devices Moderate May 1, 2013
RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and rad…
FDA Devices Moderate Apr 24, 2013