Accuray recalls

Accuray has 22 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 8 Jul 2026. 2 are still ongoing. 2 were reported in the last 12 months.

Total recalls22since 2013

Last 12 months2reported

Class I00% of total

Ongoing2latest 8 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 1 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 2Jul 0 0

Severity split

Class I 0 0%Class II 22 100%Class III 0 0%

Why accuray is recalled

Other Reasons1359%
Device Malfunction941%

Product types

By year

202629%
202515%
202315%
2021314%
201929%
2018627%
2016314%
201429%
201329%

Ongoing accuray recalls

2 active

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide

All accuray recalls, newest first

22 total

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
5 Feb 2025Device	CLASS II	CyberKnife Treatment Delivery System recalled by Accuray Incorporated	Accuray	Other	Nationwide
6 Sep 2023Device	CLASS II	Upper roller bracket recalled by Accuray Incorporated	Accuray	Device Malfunction	Nationwide
24 Mar 2021Device	CLASS II	CyberKnife Treatment Delivery System recalled by Accuray Incorporated	Accuray	Other	Nationwide
13 Jan 2021Device	CLASS II	TomoTherapy Treatment System recalled by Accuray Incorporated	Accuray	Other	Nationwide
13 Jan 2021Device	CLASS II	TomoTherapy Treatment Delivery System with iDMS recalled	Accuray	Other	Nationwide
12 Jun 2019Device	CLASS II	CyberKnife VSI, Part Numbers: a) recalled by Accuray Incorporated	Accuray	Other	WI
12 Jun 2019Device	CLASS II	CyberKnife M6, Part Numbers: a) recalled by Accuray Incorporated	Accuray	Other	WI
14 Nov 2018Device	CLASS II	CyberKnife M6 recalled by Accuray Incorporated	Accuray	Device Malfunction	WI
26 Sep 2018Device	CLASS II	Ashland(TM) Box Film Ball Cube II EBT3 recalled by Accuray Incorporated	Accuray	Other	Nationwide
3 Jan 2018Device	CLASS II	Hi-Art(R) System recalled by Accuray Incorporated	Accuray	Other	WI
3 Jan 2018Device	CLASS II	TomoHD(R) System recalled by Accuray Incorporated	Accuray	Other	WI
3 Jan 2018Device	CLASS II	TomoH(R) System recalled by Accuray Incorporated	Accuray	Other	WI
3 Jan 2018Device	CLASS II	TomoHDA(R) System recalled by Accuray Incorporated	Accuray	Other	WI
28 Dec 2016Device	CLASS II	CyberKnife Robotic Radiosurgery Systems recalled by Accuray Incorporated	Accuray	Other	27 states
21 Dec 2016Device	CLASS II	CyberKnife Robotic Radiosurgery System using recalled	Accuray	Device Malfunction	12 states
17 Feb 2016Device	CLASS II	CyberKnife Robotic recalled by Accuray Incorporated	Accuray	Device Malfunction	Nationwide
26 Nov 2014Device	CLASS II	CyberKnife Robotic Radiosurgery System recalled by Accuray Incorporated	Accuray	Device Malfunction	26 states
5 Feb 2014Device	CLASS II	CyberKnife Robotic Radiosurgery System recalled by Accuray Incorporated	Accuray	Other	Nationwide
1 May 2013Device	CLASS II	RoboCouch Patient Positioning System recalled by Accuray Incorporated	Accuray	Device Malfunction	Nationwide
24 Apr 2013Device	CLASS II	CyberKnife System Medical Physicist recalled by Accuray Incorporated	Accuray	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.