Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberM65810604640 UDI-DI	Date27 Jun 2018Listed	StatusListed GUDID: in commercial distribution

Recalls

8 recalls · FDA

- Terminated Z-0784-2021 FDA Class II initiated 10 Dec 2020
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
4 recalls, same reason
- Terminated Z-0288-2018 FDA Class II initiated 17 Nov 2017
- Terminated Z-0289-2018 FDA Class II initiated 17 Nov 2017
- Terminated Z-0287-2018 FDA Class II initiated 17 Nov 2017
- Terminated Z-0286-2018 FDA Class II initiated 17 Nov 2017
Uncontrolled couch Z-axis movement (descent)
- Terminated Z-0507-2015 FDA Class II initiated 21 Nov 2014
Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.
- Terminated Z-2239-2014 FDA Class II initiated 17 Jul 2014
Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions.
- Terminated Z-2240-2014 FDA Class II initiated 16 Jul 2014
Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.

1 jurisdiction

United States — GUDID listing Listed

GUDID

Generic Name: Linear accelerator system
Model / Ref / Catalog: 1060464
Description: Software, TomoApps, Version 5.1.2 Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™