Z-0785-2021Class II

TomoTherapy Treatment Delivery System with iDMS -

Name: Z-0785-2021 TomoTherapy Treatment Delivery System with iDMS -
Creator: Accuray Incorporated
Published: 2020-12-10
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2020-12-10 / Terminated / root cause: software

FDA source

Accuray Incorporated began a recall of TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy... on 2020-12-10. FDA classified it as Class II and gives the reason as ""MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0785-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-10
Posted: 2021-01-07
Terminated: 2022-09-26
Recalling firm: Accuray Incorporated
Product: TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Root cause tag: software
FDA root cause: Software Design Change
Action: Urgent Medical Device Recall "MLC tickle error" issue during TomoHelical deliver was sent to customers beginning 12/10/2020. Accuray is planning software releases that will address this issue. All TomoTherapy systems at affected software versions will be upgraded to these versions once released.
Quantity in commerce: 8 units
Distribution: Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates.
Product codes and lots: Product Codes: 104430, 1018286, H-0000-0003, 1018283. System Version: 1.2 (also referred to as 5.6.2). Serial Numbers: 110105, 110219, 110221, 110267, 110284, 110290, 110308, 110368,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0785-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0784-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0785-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07

Product code IYE

K171837Class IITomoTherapy Treatment Delivery System with iDMSAccuray Incorporated / cleared 2017-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)