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All Recalls

Every Accuray Incorporated Recall

Sorted by most recent. Click any recall for full details.

14 recalls
High RiskFDA
Accuray Incorporated
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery Sy...
Medical Devices·212 affected·Dec 23, 2024
High RiskFDA
Accuray Incorporated
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for...
Medical Devices·243 affected·Feb 26, 2021
High RiskFDA
Accuray Incorporated
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of ra...
Medical Devices·8 affected·Dec 10, 2020
High RiskFDA
Accuray Incorporated
CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic ra...
Medical Devices·93 affected·Sep 26, 2018
High RiskFDA
Accuray Incorporated
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Medical Devices·259 affected·Aug 31, 2018
High RiskFDA
Accuray Incorporated
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated syste...
Medical Devices·87 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system ...
Medical Devices·29 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system...
Medical Devices·118 affected·Nov 17, 2017
High RiskFDA
Accuray Incorporated
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for t...
Medical Devices·115 affected·Dec 6, 2016
High RiskFDA
Accuray Incorporated
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery ...
Medical Devices·226 affected·Jan 22, 2016
High RiskFDA
Accuray Incorporated
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for tr...
Medical Devices·84 affected·Oct 31, 2014
High RiskFDA
Accuray Incorporated
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided ...
Medical Devices·302 affected·Jan 13, 2014
High RiskFDA
Accuray Incorporated
RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosur...
Medical Devices·16 affected·Mar 27, 2013
High RiskFDA
Accuray Incorporated
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris ...
Medical Devices·176 affected·Mar 19, 2013