Accuray Incorporated
Madison, WI
This page shows every FDA and USDA recall linked to Accuray Incorporated. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
15
Total Recalls
2011
First Recall
2025
Most Recent
CyberKnife Treatment Delivery System, REF 0660000
The CyberKnife System may be labeled as CyberKnife M6TM or...
Jan 27, 2025
· Device
Completed
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery S...
Aug 31, 2023
· Device
Completed
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and...
Feb 26, 2021
· Device
Terminated
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning...
Dec 10, 2020
· Device
Terminated
TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delive...
Dec 10, 2020
· Device
Terminated
CyberKnife M6, Part Number 054000-004
The CyberKnife M6 Systems are indicated for treatment planning and ima...
Sep 26, 2018
· Device
Terminated
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E
Product is used to calibrate CyberKnife system...
Sep 20, 2018
· Device
Terminated
CyberKnife VSI, Part Numbers:
a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan
b) 03...
Apr 10, 2018
· Device
Terminated
CyberKnife M6, Part Numbers:
a) 0660000: CyberKnife Treatment Delivery System
b) 053101-010: CyberKnife M6 FI...
Apr 10, 2018
· Device
Terminated
TomoHD(R) System, Model Number 1018283
Product Usage:
The TomoTherapy treatment system is intended to be used...
Nov 17, 2017
· Device
Terminated
TomoHDA(R) System, Model Number 1018286
Product Usage:
The TomoTherapy treatment system is intended to be use...
Nov 17, 2017
· Device
Terminated
Hi-Art(R) System, Model Number H-000-0003
Product Usage:
The TomoTherapy treatment system is intended to be u...
Nov 17, 2017
· Device
Terminated
TomoH(R) System, Model Number 1018284
Product Usage:
The TomoTherapy treatment system is intended to be used...
Nov 17, 2017
· Device
Terminated
HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003.
The TomoTherapy HI-ART System is intended to be use...
Aug 31, 2011
· Device
Terminated
TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717
The TomoTherapy HI-AR...
Jul 7, 2011
· Device
Terminated