CLASS II Device recall · Reported 13 Jan 2021 · FDA Enforcement Report

TomoTherapy Treatment System recalled by Accuray Incorporated

Accuray is recalling TomoTherapy Treatment System, distributed nationwide in the US. The recall was initiated on 10 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Codes: H-0000-0003, 104430, 1018284. System Version 5.1.5. Serial Numbers: 110210, 110319, 110340, 110366, 110383, 110418, 110468

Quantity recalled7 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0784-2021
FDA event ID: 86993
Recalling firm: Accuray, Madison, WI
Classification: Class II
Status: Terminated
Recall initiated: 10 Dec 2020
FDA classified: 7 Jan 2021
Reported: 13 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Dec 2020	Recall initiated by company
7 Jan 2021	Classified by FDA	+28 days
13 Jan 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

Product as listed by the FDA

TomoTherapy Treatment System - 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.

Where it was distributed

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.

Nationwide California Florida Illinois North Dakota New Jersey Oklahoma Utah

Questions about this recall

Why was it recalled?

"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

Which lots are affected?

Product Codes: H-0000-0003, 104430, 1018284. System Version 5.1.5. Serial Numbers: 110210, 110319, 110340, 110366, 110383, 110418, 110468

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 86993

This product is part of a recall event; the main page for the event is TomoTherapy Treatment Delivery System with iDMS recalled.

Reported	Class	Recall	Company	Reason	Where
13 Jan 2021	CLASS II	TomoTherapy Treatment Delivery System with iDMS recalled	Accuray	Other	Nationwide

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8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
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